Fecal microbiota transplant with prebiotic nutrition for functional constipation

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

This will try fecal microbiota transplantation combined with a prebiotic nutrition plan to see if it helps adults aged 18–70 with chronic functional constipation that hasn’t improved with diet or laxatives.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 5 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Peking Union Medical College Hospital (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT07387952 on ClinicalTrials.gov

What this trial studies

This pilot interventional trial at Peking Union Medical College Hospital will give adults with Rome IV functional constipation fecal microbiota transplantation (FMT) combined with a targeted prebiotic nutritional intervention using a co-localization strategy. Participants must be 18–70 years old, have symptoms for at least six months, and have failed standard dietary measures and at least two laxatives or probiotics. Investigators will monitor safety and clinical outcomes such as stool frequency and consistency, and will analyze changes in fecal microbiota composition and metabolomic profiles. Outcomes will be compared over follow-up visits to determine whether the combined intervention produces clinical improvement and acceptable safety.

Who should consider this trial

Good fit: Ideal candidates are adults 18–70 with Rome IV functional constipation for at least six months who have not responded to dietary measures and at least two laxatives or probiotic treatments.

Not a fit: People who are pregnant or breastfeeding, who meet criteria for IBS rather than functional constipation, or who have secondary causes of constipation or contraindications to FMT are unlikely to benefit.

Why it matters

Potential benefit: If successful, the combined FMT and prebiotic approach could increase bowel movements, improve stool consistency, and reduce reliance on laxatives without surgery.

How similar studies have performed: Prior research suggests probiotics, prebiotics, and FMT can help chronic constipation, but combining FMT with a co-localized nutritional prebiotic intervention is a novel, pilot approach.

Eligibility criteria

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.

Where this trial is running

Beijing

• Peking Union Medical College Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Pengguang Yan

Conditions Constipation - Functional; Fecal Microbiota Transplantation; Chronic Constipation