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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Enrolling

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

Treatments: Procedure: FMT

Study type: Interventional

Funder types: Other

Identifiers

NCT07387952

I-25PJ1600

Details and patient eligibility

About

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.

Enrollment: 5 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

FMT with nutritional intervention group

Experimental group

Description:

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.

Treatment:

Procedure: FMT