An interventional study of MetProUltima in Gut Dysbiosis, sponsored by NovoBliss Research Pvt Ltd. Completed at 1 site in India. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-03.
Sponsored by NovoBliss Research Pvt Ltd · Not applicable, Interventional, and Other
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This is prospective, open-label, single-arm, proof of science, clinical safety and efficacy study of MetProUltima in healthy adult human subjects having symptoms of Gut Dysbiosis (heart burn, bloating, constipation).
A total of up to 14 subjects will be enrolled to get 12 evaluable subjects complete the study.
The potential subjects will be screened as per the inclusion \& exclusion criteria only after obtaining written informed consent from the subjects. Subjects having symptoms of gut dysbiosis like burning sensation, bloating nausea and altered bowel habit, digestion issues, aching joints and high tendency of falling sick, chronic fatigue, constipation, diarrhoea will be enrolled in the study. The subjects will be instructed to visit the facility as per the below visits.
Visit 01 (Day -01): Screening, Blood Sample Collection Visit 02 (Day 01): Enrolment, Faecal Sample Collection, Test Product Dispensing Visit 03 (Day 45 ±2 Days): Treatment usage period, Evaluations Visit 04 (Day 90 ±2 Days): Treatment usage period, Evaluations and End of study.
188 studies on the registry are indexed under Dysbiosis; 65 are open to participants now.
This study's enrollment of 14 is below the median of 60 across 132 interventional studies indexed under Dysbiosis.
Browse Dysbiosis studies →NovoBliss Research Pvt Ltd is the lead sponsor of 47 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Test product Name: MetProUltima Marketed By\| Manufactured By: Meteoric Biopharmaceuticals Private Limited Mode of Usage: Take one capsule after each meal, twice daily. Frequency: Twice a Day Route of Administration: Oral
Other: MetProUltima
Test product Name: MetProUltima Marketed By\| Manufactured By: Meteoric Biopharmaceuticals Private Limited Mode of Usage: Take one capsule after each meal, twice daily. Frequency: Twice a Day Route of Administration: Oral
Changes in stool consistency based on the Bristol Stool Criteria
To evaluate the effectiveness of the test product in terms of change in stool based on the Bristol Stool Criteria categorizes stools into one of seven stool types ranging from type 1 (hard lumps) to type 7 (watery diarrhoea).
Time frame: Baseline before usage of the test product on Day 01, and after usage of the test product on Day 45 and on Day 90
Change in faecal microbiota using 16s Metagenome sequencing
To evaluate the effectiveness of test product in terms of change in faecal microbiota using 16s Metagenome sequencing
Time frame: Baseline at Day 1, and on Day 90.
Abbreviated physical examinations in terms of frequency of sensation of defecation
To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of frequency of sensation of defecation according to a 5-point Likert scale, with a score ranging from 0 (no symptoms) to 20 (very severe symptoms
Time frame: Baseline Day 1, Day 45 and on Day 90
Abbreviated physical examinations in terms of bloating
To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of bloating in which scoring done as less than 1 week=1, less than1 month=2, less than 2 months=3 and more than 2 months=4
Time frame: Baseline Day 1, Day 45 and on Day 90
Abbreviated physical examinations in terms of nausea
To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of nausea where scoring determined no nausea=0, mild nausea=1-2, moderate nausea 3-6, and severe nausea7-9
Time frame: Baseline Day 1, Day 45 and on Day 90
Abbreviated physical examinations in terms of altered bowel habit.
To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of altered bowel habit in which scoring done as less than 1 week=1, less than1 month=2, less than 2 months=3 and more than 2 months=4
Time frame: Baseline Day 1, Day 45 and on Day 90
Abbreviated physical examinations in terms of digestion issues
To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of digestion issues in which scoring done on yes or no
Time frame: Baseline Day 1, Day 45 and on Day 90
Abbreviated physical examinations in terms of aching joints
To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of aching joints in which scoring done as less than 1 week=1, less than1 month=2, less than 2 months=3 and more than 2 months=4
Time frame: Baseline Day 1, Day 45 and on Day 90
Abbreviated physical examinations in terms of chronic fatigue
To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of chronic fatigue in which scoring done as less than 1 week=1, less than1 month=2, less than 6 months=3 and more than 6 months=4
Time frame: Baseline Day 1, Day 45 and on Day 90
Abbreviated physical examinations in terms of constipation for Frequency of bowel movements
To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of constipation for Frequency of bowel movements in which scoring done 1-2 times per 1-2 days=1 and less than once per month=4
Time frame: Baseline Day 1, Day 45 and on Day 90
Abbreviated physical examinations in terms of constipation for Completeness: feeling incomplete evacuation
To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of constipation for Completeness: feeling incomplete evacuation in which scoring done never=0 and always=4
Time frame: Baseline Day 1, Day 45 and on Day 90
Abbreviated physical examinations in terms of constipation for Time: minutes in lavatory per attempt
To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of constipation for Time: minutes in lavatory per attempt in which scoring done Less than 5=0 and More than 30=4
Time frame: Baseline Day 1, Day 45 and on Day 90
Abbreviated physical examinations in terms of constipation for Failure: unsuccessful attempts for evacuation per 24 hours
To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of constipation for Failure: unsuccessful attempts for evacuation per 24 hours in which scoring done never=0 and More than 9 =4
Time frame: Baseline Day 1, Day 45 and on Day 90
Abbreviated physical examinations in terms of constipation for Difficulty: painful evacuation effort
To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of constipation for Difficulty: painful evacuation effort in which scoring done never=0 and always =4
Time frame: Baseline Day 1, Day 45 and on Day 90
Abbreviated physical examinations in terms of constipation for Pain: abdominal pain
To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of constipation for Pain: abdominal pain in which scoring done never=0 and always =4
Time frame: Baseline Day 1, Day 45 and on Day 90
Abbreviated physical examinations in terms of constipation for Assistance: type of assistance
To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of constipation for Assistance: type of assistance in which scoring done without assistance=0 and Digital assistance or enema =2
Time frame: Baseline Day 1, Day 45 and on Day 90
Abbreviated physical examinations in terms of constipation for History: duration of constipation (years)
To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of constipation for History: duration of constipation (years) in which scoring done 0=0 and more than 20 =4
Time frame: Baseline Day 1, Day 45 and on Day 90
Abbreviated physical examinations in terms of diarrhoea
To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of diarrhoeawhere score, severe diarrhea - having more than 10 loose, watery stools in a single day (24 hours). Moderate diarrhea -having more than a few but not more than 10 diarrhea stools in a day and Mild
Time frame: Baseline Day 1, Day 45 and on Day 90
Effectiveness by biomarkers like CRP (C reactive protein).
To assess the effectiveness of the test product by Biomarkers like CRP(C reactive protein)
Time frame: baseline Day 01 and after usage of the test product on Day 90.
Effectiveness by biomarkers like IL-6 (Interleukin-6).
To assess the effectiveness of the test product by Biomarkers IL-6 (Interleukin-6)
Time frame: baseline Day 01 and after usage of the test product on Day 90.
Effectiveness of the test product in terms of subject perception questionnaire where scoring by licert scale where 1 = not at all and 5=Extremely
To assess the effectiveness of the test product in terms of subject perception questionnaire
Time frame: Baseline before usage of the test product on Day 01 and after usage of the test product, on Day 45 and on Day 90
change in lab parameters-Hemoglobin
To assess the effectiveness of the test product in terms of change in lab parameters Hemoglobin
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-Hematocrit
To assess the effectiveness of the test product in terms of change in lab parameters Hematocrit
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-RBC Counts (Red Blood Corpuscle)
To assess the effectiveness of the test product in terms of change in lab parameters RBC Counts (Red Blood Corpuscle)
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-MCV (Mean corpuscular volume)
To assess the effectiveness of the test product in terms of change in lab parameters MCV (Mean corpuscular volume)
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-MCH (mean corpuscular hemoglobin)
To assess the effectiveness of the test product in terms of change in lab parameters MCH (mean corpuscular hemoglobin)
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-MCHC (Mean corpuscular hemoglobin concentration)
To assess the effectiveness of the test product in terms of change in lab parameters MCHC (Mean corpuscular hemoglobin concentration)
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-RDW (Red cell distribution width)
To assess the effectiveness of the test product in terms of change in lab parameters RDW (Red cell distribution width)
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-WBC Counts (White blood cells)
To assess the effectiveness of the test product in terms of change in lab parameters WBC Counts (White blood cells)
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-Neutrophils
To assess the effectiveness of the test product in terms of change in lab parameters Neutrophils
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-Lymphocytes
To assess the effectiveness of the test product in terms of change in lab parameters Lymphocytes
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-Eosinophils
To assess the effectiveness of the test product in terms of change in lab parameters Eosinophils
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-Monocytes
To assess the effectiveness of the test product in terms of change in lab parameters Monocytes
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-Basophils
To assess the effectiveness of the test product in terms of change in lab parameters Basophils
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-RBC morphology
To assess the effectiveness of the test product in terms of change in lab parameters RBC morphology
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-Platelet Count
To assess the effectiveness of the test product in terms of change in lab parameters Platelet Count
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-Random Blood Sugar
To assess the effectiveness of the test product in terms of change in lab parameters Random Blood Sugar
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-Total Serum Cholesterol
To assess the effectiveness of the test product in terms of change in lab parameters Total Serum Cholesterol
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-Triglyceride
To assess the effectiveness of the test product in terms of change in lab parameters Triglyceride
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-HDL (High-density lipoprotein cholesterol)
To assess the effectiveness of the test product in terms of change in lab parameters HDL (High-density lipoprotein cholesterol)
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-LDL (Low-density lipoprotein)
To assess the effectiveness of the test product in terms of change in lab parameters LDL (Low-density lipoprotein)
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-Serum Creatinine
To assess the effectiveness of the test product in terms of change in lab parameters Serum Creatinine
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in Urine Routine and Microscopy -Color
To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Color
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in Urine Routine and Microscopy -Transparency
To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Transparency
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in Urine Routine and Microscopy -Specific Gravity
To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Specific Gravity
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in Urine Routine and Microscopy -pH
To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -pH
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in Urine Routine and Microscopy -Albumin
To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Albumin
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in Urine Routine and Microscopy -Glucose
To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Glucose
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in Urine Routine and Microscopy -Bile Salts
To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Bile Salts
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in Urine Routine and Microscopy -Bile Pigments
To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Bile Pigments
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in Urine Routine and Microscopy -Bilirubin
To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Bilirubin
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in Urine Routine and Microscopy -Urobilinogen
To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Urobilinogen
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in Urine Routine and Microscopy -Ketone
To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Ketone
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in Urine Routine and Microscopy -Nitrite
To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Nitrite
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in Urine Routine and Microscopy -RBCs (Red Blood Corpuscle)
To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -RBCs (Red Blood Corpuscle)
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in Urine Routine and Microscopy -Leucocyte
To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Leucocyte
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in Urine Routine and Microscopy -WBC (White blood cell)
To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -WBC (White blood cell)
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in Urine Routine and Microscopy -Epithelial Cell
To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Epithelial Cell
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in Urine Routine and Microscopy -Casts
To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Casts
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in Urine Routine and Microscopy -Crystals
To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Crystals
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
Adverse events
Safety will be determined by treatment-emergent adverse events such as allergies, diarrhoea, bloating, nausea, headache assessed by the study investigator.
Time frame: Baseline Day 1, Day 45 and on Day 90
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2024 to primary completion in Feb 2025, 3 months.
Of 71 non-industry interventional studies with no phase under Dysbiosis, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 28. This study's 3 months is below that.
Counting every sponsor, half of 83 studies reached it within 19 months; a quarter within 10 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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