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

NCT07387952 | Recruiting

• 1 other identifier: I-25PJ1600
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Constipation - Functional; Fecal Microbiota Transplantation (FMT); Chronic Constipation

Outcome Measures

Primary Outcomes (3)

• Frequency of Defecation (Spontaneous Bowel Movements)

  The number of Spontaneous Bowel Movements (SBM) per week recorded by the participant in a diary.

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

• Stool Consistency Assessed by Bristol Stool Form Scale (BSFS)

  Stool consistency is evaluated using the Bristol Stool Form Scale. The scale ranges from Type 1 (Separate hard lumps) to Type 7 (Liquid consistency). Type 1 and 2 indicate constipation, while Type 3 and 4 are considered normal. Higher scores indicate looser stool consistency.

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

• Severity of Defecation Straining

  Patient-reported assessment of the effort required to defecate. Participants rate their straining severity on a scale (e.g., from 0 to 3, where 0 represents no straining and 3 represents severe straining). Higher scores indicate worse symptoms.

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

Secondary Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events

  From baseline through Week 24

• Change in Gut Microbiota Composition Assessed by Metagenomic Sequencing

  Baseline, Weeks 2, 4, 8, 12, 18, and 24

Study Arms (1)

FMT with nutritional intervention group

EXPERIMENTAL

Fecal microbiota transplantation (FMT) is a method for treating imbalances in the intestinal microbiota, by extracting a portion of feces from a healthy individual that contains a diverse population of beneficial bacteria, processing it, and transplanting it into the digestive system of the recipient to restore a balanced intestinal microbiota. Nutritional intervention involves high dietary fiber preparation.

Procedure: FMT

Interventions

FMT PROCEDURE

In this group, colonoscopy is performed and a colostomy is placed in the ileocecal region. Bacterial infusion is performed for 3 days with 100ml graft per day. Within 30 minutes after receiving the microbiota transplantation, take the high dietary fiber preparation and dissolve it in water according to the instructions. Blood, stool, and colonoscopy-derived mucosal samples are collected before and after FMT and Researchers conduct follow-ups.

Also known as: FMT with nutritional intervention

FMT with nutritional intervention group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 to 70.
• 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.
• Disease course requirements: Symptoms persist for at least 6 months and meet the above criteria within the last 3 months.
• Traditional treatment methods (dietary intervention, at least two laxatives or probiotics) are ineffective.

You may not qualify if:

• 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.
• Participation in other clinical trials within 3 months prior to enrollment.
• Other health problems are not suitable for participation in the study.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

MeSH Terms

Interventions

Fecal Microbiota Transplantation

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Jingnan Li, MD, Ph.D

  Peking Union Medical College Hospital, Peking Union Medical College

  STUDY CHAIR

Central Study Contacts

Pengguang Yan

CONTACT

+8618810309887; pengchengf@mail.sdu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: February 4, 2026
• Study Start: July 30, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 4, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)