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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Constipation; Constipation - Functional; Fecal Microbiota Transplantation (FMT)
• Intervention / Treatment: Procedure: FMT

• Study Type: Interventional
• Enrollment (Estimated): 5
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pengguang Yan; Phone Number: +8618810309887; Email: pengchengf@mail.sdu.edu.cn

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking Union Medical College Hospital
    • Contact: Pengguang Yan; Phone Number: +8618810309887; Email: pengchengf@mail.sdu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: FMT with nutritional intervention group; 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; 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.; Other Names: FMT with nutritional intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events	Number of participants with adverse events. Assessment includes monitoring for specific gastrointestinal symptoms (e.g., aggravation of diarrhea, abdominal discomfort/bloating) and systemic infections (e.g., secondary intestinal infection, bacteremia). Safety is assessed via telephone and offline visits.	From baseline through Week 24
Change in Gut Microbiota Composition Assessed by Metagenomic Sequencing	Fecal samples are collected to analyze the changes in the gut microbiota structure. Analysis includes the relative abundance of bacterial species and diversity indices (e.g., Shannon index) using Metastats analysis to compare pre- and post-treatment compositions.	Baseline, Weeks 2, 4, 8, 12, 18, and 24

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Study Chair: Jingnan Li, MD, Ph.D, Peking Union Medical College Hospital, Peking Union Medical College

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: August 6, 2025
• First Submitted That Met QC Criteria: January 27, 2026
• First Posted (Actual): February 4, 2026

Study Record Updates

• Last Update Posted (Actual): February 4, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics; Biological Therapy; Fecal Microbiota Transplantation
• Other Study ID Numbers: I-25PJ1600

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No