CompletedNot Applicable

The Effect of Galactooligosaccharides (GOS) on the Gut Microbiota of Lactose Intolerance Individuals

United States12 participantsStarted 2021-10-25

Plain-language summary

The purpose of this study was to identify specific microbes that change with supplementation with galactooligosaccharides-prebiotics that are associated with alleviation of lactose intolerance symptoms in lactose-intolerant human subjects.

Who can participate

Age range

19 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: \- People with lactose intolerance (formal and informal diagnosis) Fluent in English People who have a primary care provider Have to be 18 years and older Exclusion Criteria: \- Any known gastrointestinal disease or disorder, or major gastrointestinal surgery Habitual use of laxatives or antacids Diabetes Pregnancy Use of antibiotics within one month prior to the study Use of pre or probiotics within one month prior to the study Any subject who, in the opinion of a physician, has a medical or psychological condition that would preclude them from completing the study Dairy protein allergy (not lactose intolerance) Use of lactose intolerance pills such as "Lactaid" should be avoided during the course of this study

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Increase in the relative abundance of the genus Bifidobacterium and other lactose-metabolizing genera

Timeframe: 6 weeks

Trial details

NCT IDNCT06915129

SponsorOregon State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12-06

View on ClinicalTrials.gov More Modulation of the Human Gut Microbiota by Prebiotic Galactooligosaccharides (GOS) trials

Who can participate

Age range

19 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.