An observational study in Lactose Intolerance, sponsored by Indiana University. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-06.
Sponsored by Indiana University · Observational
The purpose of this study is to study the role of the enzyme (substance produced by the body that helps in a biochemical reaction like digestion in the body) responsible for digestion of lactose and the role of the gut bacteria (bacteria in the intestine) in producing symptoms of lactose intolerance.
The study involves 3 visits and will include 2 types of subjects - those who have the the diagnosis of lactose intolerance (subjects) and those who do not have lactose intolerance (controls).
Visit 1:
In total, it is estimated that the research participation will add about 1 hour to your planned procedure visit. At Visit 1 following will be done
Visit 2:
Visit 2 will take approximately 6 hours to complete. If the subject returns for Visit 2, they will do the following
Visit 3:
Visit 3 will take approximately less than one hour to complete. For those who are interested in returning for Visit 3,
Participants who complete Aim 1 and meet further eligibility criteria for Aim 2 may be contacted by research staff to return for Visit 2 (breath test). Those who are agreeable to participating and are scheduled for Visit 2 will be instructed to consume a low-fiber meal and fast for 12 hours prior to their breath test. We will contact the participant 24 to 48 hours prior to the test day as a reminder to consume a low fiber meal and fast for 12 hours.
53 studies on the registry are indexed under Lactose Intolerance; 6 are open to participants now.
This study's enrollment of 37 is below the median of 70 across 11 observational studies indexed under Lactose Intolerance.
Browse Lactose Intolerance studies →Indiana University is the lead sponsor of 986 studies on the registry; 198 are open to participants now.
Of its 148 completed or terminated interventional studies of FDA-regulated products, 118 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patient ages 18-75 presenting for upper gastrointestinal endoscopy for any indication except those outlined in the exclusion criteria below at the IU GI Endoscopy Sites including: IU North Hospital, Glen Lehman Endoscopy Suite, Springmill/Beltway Surgery Center, IU Saxony, and Eskenazi Hospital will be eligible for participation. Participants should be willing and able to sign informed consent.
Patient ages 18-75 presenting for upper gastrointestinal endoscopy for any indication except those outlined in the exclusion criteria below at the IU GI Endoscopy Sites including: IU North Hospital, Glen Lehman Endoscopy Suite, Springmill/Beltway Surgery Center, IU Saxony, and Eskenazi Hospital will be eligible for participation. Participants should be willing and able to sign .
Inclusion Criteria for Controls (Aim 1): Adult patients ages 18-75 years meeting basic eligibility criteria as listed above will be considered for inclusion. Participants should report no current or recent history of intolerance to and avoidance of dairy nor use of treatments and products for dairy intolerance.
Inclusion Criteria for Patients with Self-Reported Lactose Intolerance (Aim 1): Adult patients ages 18-75 years meeting basic eligibility criteria as listed above will be considered for inclusion. Participants should report current or recent history of intolerance to and avoidance of dairy.
Inclusion Criteria for Controls (Aim 2): All controls eligible for and completing Aim 1 will be considered eligible for inclusion. Participants should not meet any of the Aim 2 exclusion criteria.
Inclusion Criteria for Patients with Self-Reported Lactose Intolerance (Aim 1): All patients with self-reported lactose intolerance eligible for and completing Aim 1 will be considered eligible for inclusion. Participants should not meet any of the Aim 2 exclusion criteria.
Exclusion criteria (Aim 1):
Exclusion criteria (Aim 2):
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.
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.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
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.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Lactase activity
Lactase activity (µmol/min/g) will be assessed from small bowel biopsy specimens
Time frame: 1 day
Symptom severity
We will assess symptom severity using the lactose assessment tool
Time frame: 1 day
Small intestinal mucosal microbiome
The small intestinal microbiome will be assessed by 16S allele PCR sequencing (16S) and Shotgun Metagenomic Sequencing (SGS)
Time frame: 1 day
Maldigestion status
Maldigestion status will be assessed by hydrogen breath test
Time frame: 1 day
Fecal microbiome
The fecal microbiome will be assessed by 16S allele PCR sequencing (16S) and Shotgun Metagenomic Sequencing (SGS)
Time frame: 1 day
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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