Fecal microbiota transplant with prebiotic nutrition for functional constipation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Peking Union Medical College Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: Pengguang Yan
• Email: pengchengf@mail.sdu.edu.cn
• Phone: +8618810309887

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Sacral nerve stimulation for children with bowel motility problems

  This project tests sacral neuromodulation in children aged 3–18 with gastrointestinal motility disorders to see if imaging-guided, personalized implantation improves symptoms.

  Recruiting Friedrich-Alexander-Universität Erlangen-Nürnberg · Erlangen · NCT07519915

• Bowel Irrigation Techniques for Chronic Constipation and Faecal Incontinence

  This study tests two transanal irrigation devices in adults with bowel control problems to see which helps more in real-world care.

  Recruiting Qufora A/S · Southampton · NCT07473622

• Fecal transplant for chemotherapy and targeted-therapy gut side effects in advanced gastrointestinal cancer

  This trial will try oral fecal microbiota transplants (FMT) to see if they reduce chemotherapy or targeted-therapy–related gut symptoms in adults with advanced gastrointestinal cancers.

  Recruiting Phase 1 Second Affiliated Hospital, Zhejiang University, School of Medicine · Zhejiang, Hangzhou · NCT07319364

• Parents' views on physical activity for children aged 6-12 with functional constipation

  Researchers will ask parents of children aged 6-12 with functional constipation about their child's physical activity to see if supporting exercise could help symptoms and care.

  Recruiting Vastra Gotaland Region · Alingsås · NCT07300423

• Diet-driven approach to ease constipation in people with Parkinson’s

  A dietitian-guided nutritional plan is tested to see if it increases weekly bowel movements and improves gut health in adults with Parkinson’s disease and functional constipation.

  Recruiting Hospital de Clinicas de Porto Alegre · Porto Alegre, Rio Grande do Sul · NCT07213856

• Psyllium versus fructooligosaccharide for improving bowel transit in women with functional constipation

  This will test whether taking 20 g daily of psyllium or fructooligosaccharide for six days helps improve bowel movements and intestinal transit in adult women with functional constipation.

  Recruiting Federal University of Minas Gerais · Belo Horizonte, Minas Gerais · NCT07202481

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.