Poop pills and fiber: a new hope for constipation?

NCT ID NCT07387952

Disease control Sponsor: Peking Union Medical College Hospital Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study tests whether a fecal microbiota transplant (FMT) combined with a high-fiber diet can safely and effectively treat chronic constipation. Five adults with functional constipation will receive FMT via colonoscopy and take a dietary fiber supplement. Researchers will track bowel movements, stool consistency, and side effects to see if this approach works better than standard laxatives.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: fecal microbiota transplant (FMT) and high dietary fiber preparation
What this could lead to: If it works, this could point toward a new treatment for chronic constipation that doesn't rely on laxatives.
What could go wrong: This is a very small pilot study with only 5 participants, so results may not apply to everyone. The procedure involves colonoscopy and a colostomy, which carries risks like infection or discomfort.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 5 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age: 18 to 70. 2. Diagnostic criteria: Functional constipation (FC) in accordance with Rome IV criteria, which should meet the following conditions: * Symptom requirements: The following at least 2 items should occur in ≥25% of bowel movements: a. Straining during defecation; b. Hard stool (Bristol Stool Classification score 1-2); c. Feeling of incomplete evacuation; d. Rectal obstruction sensation; e. Need for finger assistance during defecation; f. Spontaneous bowel movements \<3 times per week. * It is rare to have loose stools without laxatives. * Exclusion of irritable bowel syndrome (IBS): IBS diagnosis criteria not meeting Rome IV. * Disease course requirements: Symptoms persist for at least 6 months and meet the above criteria within the last 3 months. 3. Traditional treatment methods (dietary intervention, at least two laxatives or probiotics) are ineffective. Exclusion Criteria: 1. Pregnancy or lactation. 2. Unable to take the intervention product or complete the examination as required. 3. Language expression disorder or mental illness. 4. Physical examination showed severe liver and kidney dysfunction. 5. Acute gastrointestinal disease within 4 weeks. 6. Constipation caused by surgery in the past 4 weeks. 7. History or abnormal examination: cancer, severe enteritis, intestinal obstruction, inflammatory bowel disease, hypothyroidism, mental illness, stroke, heart disease, cirrhosis, renal failure, hematopoietic system diseases, organic bowel disease suggested by colonoscopy or imaging. 8. Participation in other clinical trials within 3 months prior to enrollment. 9. Other health problems are not suitable for participation in the study.

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Conditions

The condition(s) this trial relates to.

constipation disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic constipation Constipation - functional Fecal microbiota transplantation (FMT)

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Poop pills and fiber: a new hope for constipation?

What the study statuses mean