The Effects of the Bile Acid Supplement, 7-keto Lithocholic Acid, on Human Gut Microbiota and Ris… (NCT07499414) | Clinical Trial Compass
RecruitingNot Applicable
The Effects of the Bile Acid Supplement, 7-keto Lithocholic Acid, on Human Gut Microbiota and Risk Factors for Disease.
United Kingdom40 participantsStarted 2026-04-06
Plain-language summary
In humans and most mammals, bile acids play a role in the metabolism of glucose and the transport and absorption of lipids (such as cholesterol and triglycerides), vitamins, and nutrients by allowing for emulsification (mixing) and absorption of fatty molecules that are consumed. More recently, bile acids have been discovered to influence the composition and quantity of the microorganisms in the gut microbiome. Bile acids also act as signalling molecules (like hormones) in the body, regulating important metabolic pathways and digestion.
While the majority of bile acids are recycled back to the liver, a small proportion of these bile acids enter the colon and interact with the gut microbiota. Primary bile acids, synthesized in the liver, are essential for the absorption of fat- and fat-soluble vitamins, as part of the digestive process. These primary bile acids are converted to secondary bile acids by gut bacteria, which have been shown to have benefits to health. This provides the rationale for exploring the use of a bile acid, in this case 7-keto lithocholic acid (7-KLCA), as a beneficial modulator of the gut microbiome, to help regulate metabolic and potentially other disease pathways.
Who can participate
Age range
18 Years – 65 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:
* Volunteer is healthy (good physical and mental condition, disease-free, with haemoglobin levels between 138 - 172 g/L for male and between 121 and 151 g/L for female) at the time of pre-examination
* Volunteer is aged ≥ 18 to ≤ 65 years for the duration of the study
* Volunteer is able and willing to comply with the study instructions
* Volunteer is suitable for participation in the study according to the investigator/study personnel
* Volunteer is able to give informed consent
* Volunteer must be following a non-restrictive diet according to the investigator/study personnel (no vegan, keto or fasting diets)
* Volunteer has not consumed pro- or prebiotic supplements or food products for a minimum of 4 weeks prior to starting the intervention.
* Volunteer has no gastrointestinal disorders
Exclusion Criteria:
* No command of any local language
* Gastrointestinal disorders including IBS, IBD or other conditions that might affect the gut environment
* Food allergies or intolerances
* Using drugs (e.g. antibiotics) influencing gastrointestinal function (12 weeks before intervention)
* Use of laxatives
* Clinically significant diabetes (plasma glucose test, fasting blood glucose \> 6.5 mmol/l (120 mg/dL)
* Volunteers currently involved or will be involved in another clinical/ food study for the duration of this study
* History of drug (pharmaceutical or recreational) or alcohol abuse.
* If participants are pregnant or are lactating
* Regular intake of probi…
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.