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CompletedNCT06083311SLOGUpdated Apr 9, 2025

The Efficacy of a Probiotic for Functional Constipation (FC)

An interventional study of Probiotic and Placebo in Functional Constipation, sponsored by The Archer-Daniels-Midland Company. Completed at 1 site in Germany. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-09.

Sponsored by The Archer-Daniels-Midland Company · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
55
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Investigate the effect of a probiotic (live bacteria) in individuals with functional constipation.

Read the detailed description

This study aims to investigate the safety and efficacy of live bacteria on defecation parameters in individuals with Functional Constipation. The trial will be run in Germany and will recruit adult men and women meeting the ROME-IV criteria for functional constipation.

02

Conditions studied

  • Functional Constipation

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Keywords

  • Probiotic
  • GI microbiome
  • Lactobacillus
  • Bifidobacterium
03

In context

Constipation

1,018 studies on the registry are indexed under Constipation; 139 are open to participants now.

This study's enrollment of 55 is below the median of 80 across 850 interventional studies indexed under Constipation.

Browse Constipation studies →

Lead sponsor

The Archer-Daniels-Midland Company is the lead sponsor of 19 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Males (at least 30% of total number of subjects) and females ≥ 18 years and ≤65 years old
  2. Body Mass Index (BMI) 18.5 - 30.0 kg/m2
  3. Fulfilment of the Rome IV FC diagnostic criteria at V1 and V2
  4. Self-reported average stool frequency of 3 or less bowel movements per week
  5. Self-reported average stool consistency of type 1-4 on the Bristol Stool Form Scale
  6. Cleveland Clinic Constipation Score > 8 at V1
  7. Readiness not to use any treatment/supplementation for complaints related to constipation (e.g. prokinetics, laxatives, enemas) during the study; exception: glycerol suppository and if it provides no benefit, participants are allowed to take oral laxatives (see section 0)
  8. Readiness and ability to comply with and perform the procedures requested by the protocol
  9. If receiving proton pump inhibitors (PPI), anticipated to continue PPI therapy for the duration of the trial
  10. Readiness not to have any change in habitual diet or exercise patterns over the study period

  11. Women:

    • If sexually active, commitment to use contraception methods
    • negative pregnancy testing (beta human chorionic gonadotropin test in urine) at V1
  12. Generally, in the opinion of investigator, healthy individuals (e.g. no heart failure, no malignancy) Participation is based upon written informed consent by the participant following written and oral information by the investigator regarding nature, purpose, consequences and possible risks of the clinical study.

Exclusion criteria

Exclusion Criteria:

  1. Clinically relevant (as per investigators judgement) self-reported chronic disease of the gastrointestinal tract (e.g. irritable bowel syndrome, Crohn's disease, ulcerative colitis, celiac disease, diverticulitis, malabsorption disorder), neurological, cardiovascular, endocrine/reproductive, renal, or other chronic diseases likely to affect gut motility
  2. Prior abdominal surgery in the past 3 years (except for laparoscopic appendectomy and cholecystectomy and other minor laparoscopic surgeries, as per investigator judgement, that are allowed)
  3. Ongoing regular use of products that (in the investigator's opinion) are known to cause constipation or change gastric motility (e.g. iron; opioids; sucralfate; 5-HT3 antagonists (e.g. ondansetron); antacids with magnesium, calcium, or aluminum; anticholinergic agents; calcium supplements; trycyclic antidepressants; systemic steroids)
  4. Any subjects with use of PPI within the last 8 weeks prior to Visit 1 (exception: continuous use for ≥ 8 week before Visit 1 is allowed)
  5. Post-menopausal women, defined as >12 months after the last menstrual bleeding and not using hormonal contraception
  6. Women ≥ 50 years using hormonal contraception
  7. ALARM features in the past 3 months prior to study (e.g. fever, unintentional weight loss ≥5 kg, blood in stool, vomiting) and moderate or severe anorectal problems (e.g. rectal bleeding, pelvic organ prolapse, anal fissures)
  8. Previously diagnosed lactose intolerance, gluten intolerance, cow's milk allergy and/or soya-allergy
  9. Known allergy or hypersensitivity to any ingredients of the investigational product
  10. Consumption of biotic supplements (probiotics, prebiotics, synbiotics or post-biotics) within 2 weeks prior to Visit 1 and during the study
  11. Regular consumption of fibre supplements and/or laxatives more than 1x a week
  12. Use of laxatives within 48 hrs prior to Visit 1
  13. Use of antibiotic within 4 weeks prior to Visit 1 and during the study
  14. Ongoing alcohol, drug, or medication abuse
  15. Participation in other clinical trials within 4 weeks prior to Visit 1 and during the study
  16. Planning travel for >1 week during the study duration
  17. Anticipated major changes in diet or exercise during the study
  18. Pregnant or lactating or planned to become pregnant during the study period
  19. Smoking > 5 cigarettes per week
  20. An irregular diet, an abnormal sleep cycle, or other lifestyle abnormalities, as per investigator judgement
  21. Individuals who, in the opinion of the investigator, are considered to be incompliant clinical attendees or unlikely for any reason to be able to complete the trial as required
  22. Clinically relevant deviation of screening laboratory parameters at V1
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
55 participants (actual)

Study arms

  • Experimental
    Probiotic

    Participants in this arm will receive a daily dose of 3x10\^9 Colony Forming Units (CFU) of a live bacterium, corresponding to 1 capsules daily for 28 days

    Dietary Supplement: Probiotic

  • Placebo comparator
    Placebo

    Participants in this arm will receive an equivalent placebo for 28 days

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementProbiotic

    Participants in this arm will receive a daily dose of 3x10\^9 Colony Forming Units (CFU) of a live bacterium, corresponding to 1 capsules daily for 28 days

  • Dietary supplementPlacebo

    Participants in this arm will receive an equivalent placebo for 28 days

06

What researchers measure

Primary outcomes

  1. Difference in change in Cleveland Clinic Constipation score (total) from baseline (V2) to study end (V3)

    Difference in change in Cleveland Clinic Constipation score (CCCS) (total) from baseline (V2) to study end (V3) between verum and placebo groups. Higher scores in the CCCS indicate worse constipation symptoms. (Max score: 30)

    Time frame: Baseline (V2), Day 28 (V3)

Secondary outcomes

  1. Difference in change in Cleveland Clinic Constipation score (total) at 2 week(s) after V2, compared to V2

    Difference in change in Cleveland Clinic Constipation score (CCCS) (total) from 2 weeks after V2 to study end (V3) between verum and placebo groups. Higher scores in the CCCS indicate worse constipation symptoms (Max score: 30)

    Time frame: Baseline (V2), Day 14

  2. Difference in change in Patient Assessment of Constipation - Quality of Life score (total) from V2 to V3

    Difference in change in Patient Assessment of Constipation - Quality of Life (PAC-QOL) score (total) from V2 to V3. Higher scores in the PAC-QOL indicate worse constipation symptoms (Max Score: 112)

    Time frame: Baseline (V2), Day 28 (V3)

  3. Difference in change in Patient Assessment of Constipation - Quality of Life score (total) at 2 week(s) after V2, compared to V2

    Difference in change in Patient Assessment of Constipation - Quality of Life (PAC-QOL) score (total) from 2 weeks after V2 to V3. Higher scores in the PAC-QOL indicate worse constipation symptoms (Max Score: 112)

    Time frame: Baseline (V2), Day 14

  4. Difference in Patient Assessment of Constipation - Quality of Life domain score from V2 to V3

    Difference in change in Patient Assessment of Constipation - Quality of Life (PAC-QOL) domain scores (total) from V2 to V3. Higher scores in the PAC-QOL domain scores indicate worse constipation symptoms (varying questions in each domain, each question scored 0 - 4 on Likert scale)

    Time frame: Baseline (V2), Day 28 (V3)

  5. Difference in change in Patient Assessment of Constipation - Quality of Life domain scores at 2 week(s) after V2, compared to V2

    Difference in change in Patient Assessment of Constipation - Quality of Life (PAC-QOL) domain scores (total) from 2 weeks after V2 to V2. Higher scores in the PAC-QOL domain indicate worse constipation symptoms (varying questions in each domain, each question scored 0 - 4 on Likert scale)

    Time frame: Baseline (V2), Day 14

  6. Difference in change in total reflux symptoms score from V2 to V3

    Difference in (total) reflux questionnaire scores from V2 to V3. Higher scores in the reflux questions indicate worse reflux symptoms. Max score 10.

    Time frame: Baseline (V2), Day 28 (V3)

  7. Difference in change in total reflux symptoms score at 2 weeks after V2, compared to V2

    Difference in (total) reflux questionnaire scores from 2 weeks after V2 to V2. Higher scores in the reflux questions indicate worse reflux symptoms. Max score 10.

    Time frame: Baseline (V2), Day 14

  8. Difference in change in reflux symptoms sub-scale score (i.e. individual items) from V2 to V3

    Difference in (subscale) reflux questionnaire scores from V2 to V3. Higher scores in the reflux questions indicate worse reflux symptoms. Each question is a Likert scale ranging from 1-5. Max score is 5.

    Time frame: Baseline (V2), Day 28 (V3)

  9. Difference in change in reflux symptoms sub-scale score (i.e. individual items) at 2 weeks after V2, compared to V2

    Difference in (subscale) reflux questionnaire scores from 2 weeks after V2 to V2. Higher scores in the reflux questions indicate worse reflux symptoms. Each question is a Likert scale ranging from 1-5. Max score is 5.

    Time frame: Baseline (V2), Day 14

  10. Difference in proportion of stools in different Bristol Stool Form Scale categories (1-2, 3-4, 5-7) at 1, 2, 3 week(s) after V2 and at V3, each compared to V2

    Proportion of stool in each Bristol Stool Form Scale (BSFS) category at 1, 2, 3 week(s) after V2 and at V3, each compared to V2. BSFS categories range from 1 - 7, with 1 representing hard stool and 7 representing liquid stool.

    Time frame: Baseline (V2), Day 7, Day 14, Day 21 and Day 28

  11. Difference in change in mean weekly stool frequency at 1, 2, 3 week(s) after V2 and at V3, each compared to V2

    Difference in change in mean weekly number of bowel movements at 1, 2, 3 week(s) after V2 and at V3, each compared to V2.

    Time frame: Baseline (V2), Day 7, Day 14, Day 21 and Day 28

  12. Difference in change in mean weekly number of spontaneous bowel movements (without assistance/ medication) at 1, 2, 3 week(s) after V2 and at V3, each compared to V2

    Difference in change in mean weekly number of spontaneous bowel movements (without assistance/ medication) at 1, 2, 3 week(s) after V2 and at V3, each compared to V2

    Time frame: Baseline (V2), Day 7, Day 14, Day 21 and Day 28

  13. Difference in change of the weekly degree of straining (VAS) at 1, 2, 3 week(s) after V2 and at V3, each compared to V2

    Difference in change of the weekly average degree of straining (VAS) at 1, 2, 3 week(s) after V2 and at V3, each compared to V2. Straining calculated on a 5-point Likert Scale, where 1 is no straining and 5 is very severe straining

    Time frame: Baseline (V2), Day 7, Day 14, Day 21 and Day 28

  14. Difference in change of the weekly defecation/ rectal pain (VAS) at 1, 2, 3 week(s) after V2 and at V3, each compared to V2

    Difference in change of the weekly average defecation/rectal pain at 1, 2, 3 week(s) after V2 and at V3, each compared to V2. Defecation/Rectal pain calculated on a 5-point Likert Scale, where 1 is no painand 5 is very severe pain

    Time frame: Baseline (V2), Day 7, Day 14, Day 21 and Day 28

  15. Difference in the weekly self-assessment of complete bowel emptying at 1, 2, 3 week(s) after V2 and at V3, each compared to V2

    Difference in the weekly average self-assessment of complete bowel emptying at 1, 2, 3 week(s) after V2 and at V3, each compared to V2. Self assessment of complete bowel emptying conducted with a 'yes' or 'no' question

    Time frame: Baseline (V2), Day 7, Day 14, Day 21 and Day 28

  16. Difference in weekly average use of laxatives at 1, 2, 3 week(s) after V2 and at V3, each compared to V2

    Difference in weekly average use of laxatives at 1, 2, 3 week(s) after V2 and at V3, each compared to V2

    Time frame: Baseline (V2), Day 7, Day 14, Day 21 and Day 28

  17. Difference in weekly need for digital assistance at 1, 2, 3 week(s) after V2 and at V3, each compared to V2

    Difference in weekly average need for digital assistance at 1, 2, 3 week(s) after V2 and at V3, each compared to V2

    Time frame: Baseline (V2), Day 7, Day 14, Day 21 and Day 28

  18. Difference in short chain fatty acids (SCFA) in stool samples collected prior to V2 and prior to V3

    Difference in short chain fatty acids (SCFA) in stool samples collected prior to V2 and prior to V3.

    Time frame: Baseline (V2), Day 28 (V3)

  19. Difference in findings of microbiome assessment using metagenomics techniques of stool samples collected prior to V2 and prior to V3

    Difference in findings of microbiome assessment using metagenomics techniques of stool samples collected prior to V2 and prior to V3

    Time frame: Baseline (V2), Day 28 (V3)

  20. Difference in findings of targeted metabolomic analysis of stool samples collected prior to V2 and prior to V3

    Difference in findings of targeted metabolomic analysis of stool samples collected prior to V2 and prior to V3

    Time frame: Baseline (V2), Day 28 (V3)

  21. Percentage of subjects with matching records of blinded assessment concern-ing the IP type they received (verum, placebo) and the actual IP assignment

    Percentage of subjects with matching records of blinded assessment concern-ing the IP type they received (verum, placebo) and the actual IP assignment

    Time frame: Day 28 (V3)

  22. Assessment of benefit by subject and investigator at V3 (4 point categorical scale)

    Assessment of benefit by subject and investigator at V3. 4 point scale, where 1 = poor and 4 = very good

    Time frame: Day 28 (V3)

  23. Assessment of the number of adverse events between the intervention and placebo

    Assessment of the number of adverse events between the intervention and placebo

    Time frame: Day 28 (V3)

07

Study locations

1 site
  • analyze & realize GmbH
    Berlin, 10369, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06083311
Lead sponsor
The Archer-Daniels-Midland Company
Collaborators
Analyze & Realize
Responsible party
Sponsor
First posted
Oct 16, 2023
Start date
Oct 19, 2023
Primary completion
Dec 17, 2024
Completion
Dec 17, 2024
Last update
Apr 9, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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