RecruitingNot Applicable

The Safety and Efficacy of Fecal Microbiota Transplantation Combined With Nutritional Intervention in the Treatment of Functional Constipation：a Pilot Study

China5 participantsStarted 2025-07-30

Plain-language summary

Chronic constipation is a common gastrointestinal disease with a global prevalence of about 15%, significantly affecting daily life and quality of life. Traditional treatments primarily rely on laxatives, which may lead to adverse effects with prolonged use, while surgical interventions have limited patient acceptance. Recent studies indicate that gut microbiota therapies-including probiotics, prebiotics, synbiotics, postbiotics, and fecal microbiota transplantation (FMT)-can effectively manage chronic constipation. This study aims to investigate the safety and efficacy of FMT combined with a prebiotic nutritional intervention (using a co-localization strategy) in the treatment of functional constipation. Additionally, the investigators will explore changes in fecal microbiota and metabolomic profiles following the treatment.

Who can participate

Age range18 Years – 70 Years

SexALL

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

Inclusion criteria

✓. Age: 18 to 70.
✓. Diagnostic criteria: Functional constipation (FC) in accordance with Rome IV criteria, which should meet the following conditions:

Exclusion criteria

✕. Traditional treatment methods (dietary intervention, at least two laxatives or probiotics) are ineffective.
✕. Pregnancy or lactation.
✕. Unable to take the intervention product or complete the examination as required.
✕. Language expression disorder or mental illness.
✕. Physical examination showed severe liver and kidney dysfunction.
✕. Acute gastrointestinal disease within 4 weeks.
✕. Constipation caused by surgery in the past 4 weeks.
✕. 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.

What they're measuring

Frequency of Defecation (Spontaneous Bowel Movements)

Timeframe: Baseline, Weeks 4, 8, 12, 18, and 24

Stool Consistency Assessed by Bristol Stool Form Scale (BSFS)

Timeframe: Baseline, Weeks 4, 8, 12, 18, and 24

Severity of Defecation Straining

Timeframe: Baseline, Weeks 4, 8, 12, 18, and 24

Trial details

NCT IDNCT07387952

SponsorPeking Union Medical College Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Pengguang Yan

+8618810309887 pengchengf@mail.sdu.edu.cn

View on ClinicalTrials.gov More Constipation - Functional trials

Plain-language summary

Who can participate

Age range18 Years – 70 Years

SexALL

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

✓. Age: 18 to 70.
✓. Diagnostic criteria: Functional constipation (FC) in accordance with Rome IV criteria, which should meet the following conditions:

Exclusion criteria

✕. Traditional treatment methods (dietary intervention, at least two laxatives or probiotics) are ineffective.
✕. Pregnancy or lactation.
✕. Unable to take the intervention product or complete the examination as required.
✕. Language expression disorder or mental illness.
✕. Physical examination showed severe liver and kidney dysfunction.
✕. Acute gastrointestinal disease within 4 weeks.
✕. Constipation caused by surgery in the past 4 weeks.
✕. 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.