A Study on the Effects of Combined FMT on Gut Microbiota and Eating Disorder Symptoms in AN

NCT06744751 | Not Yet Recruiting DMC

• 1 other identifier: 2024-28
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to determine if Fecal Microbiota Transplantation (FMT) is effective in treating Anorexia Nervosa (AN). The study will also explore how FMT works. The main questions it aims to answer are:

• Be hospitalized
• Take FMT or placebo daily for 6 days
• Provide stool and blood samples before and after FMT
• Visit the clinic every 4 weeks for check-ups and tests

Conditions

Anorexia Nervosa

Keywords

Anorexia nervosa; Tretment of Anorexia nervosa; Gastrointestinal symptoms in Anorexia nervosa; Gut microbiota

Outcome Measures

Primary Outcomes (2)

• Hight

  Measurement of morning height will be taken using the same height-measuring device.

  baseline，follow-up (4,8,12 week)

• Weight

  Morning fasting weight will be measured using the same scale.

  baseline，follow-up (4,8,12 week)

Secondary Outcomes (7)

• Eating Disorder Examination Questionnaire 6.0(EDEQ-6.0)

  baseline，follow-up (4,8,12 week)

• Gastrointestinal Symptom Rating Scale(GSRS)

  recuitment， follow-up（4、8、12 week）

• Hamilton Depression Scale (HAMD)

  baseline，follow-up（4、8、12 week）

• Patient Health Questionnaire-9 (PHQ-9)

  baseline, follow-up(4, 8, 12 week)

• Clinical Global Impression (CGI)

  baseline, follow-up(4, 8, 12 week)

Study Arms (2)

Fecal Microbiota Transplantation

ACTIVE COMPARATOR

The FMT capsules used in this study contain processed, frozen stool from healthy donors, providing gut microbiota from these individuals. The FMT capsules meet relevant manufacturing standards. Patients take the capsules twice daily, with a dose of 6 or 10 capsules per day, over a period of 6 days (for a total of 72 or 120 capsules). Select the capsule dosage based on age. For children under 18 years old, take 10 capsules at a time. For adults aged 18 and above, take 6 capsules at a time.

Biological: Fecal Microbiota Transplantation

Placebo

PLACEBO COMPARATOR

The placebo capsules, manufactured by the same company, are identical in appearance, size, color, dosage form, weight, and taste to the FMT capsules. Starch is used as the main ingredient to mimic the FMT capsules.

Drug: Placebo

Interventions

Fecal Microbiota Transplantation BIOLOGICAL

Patients take the capsules twice daily, with a dose of 6 or 10 capsules per day, for a total of 6 days (72 or 120 capsules in total). Select the capsule dosage based on age. For children under 18 years old, take 10 capsules at a time. For adults aged 18 and above, take 6 capsules at a time. Both the FMT and placebo capsules are identical in appearance, size, color, form, weight, and taste, with the placebo containing starch as the main ingredient.

Fecal Microbiota Transplantation

Placebo DRUG

Manufactured by the same company, the placebo capsules contain starch as the main ingredient and are identical in appearance, size, color, dosage form, weight, and taste to the FMT capsules. They are administered twice daily, 6 or 10 capsules per dose (selected by age), for 6 days.

Placebo

Eligibility Criteria

• Age: 12 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Female, aged 12-35 years, meets DSM-5 diagnostic criteria for anorexia nervosa.
• BMI \> 14 kg/m²; for children/adolescents, BMI \> the 0.3 percentile for their age.
• Presence of digestive symptoms (e.g., constipation, bloating, diarrhea).
• Duration of the disease (since the onset of dieting and weight loss) is less than two years.
• Each patient must understand the nature of this study and sign an informed consent form.

You may not qualify if:

• Co-morbid severe mental disorders such as schizophrenia, bipolar disorder, intellectual disability, persistent delusional disorder, schizoaffective disorder, or organic mental disorders.
• Substance abusers/addicts, individuals with a high suicide risk, or those with strong destructive impulses or antisocial behavior.
• Those with severe low body mass anorexia nervosa (e.g., blood pressure \< 80/50 mmHg, heart rate \< 40 beats/min, weight loss \> 1 kg per week, or those requiring assistance in sitting or squatting in a prone position).
• Patients with severe somatic diseases or comorbidities, including:
• Organic intestinal lesions such as congenital megacolon, intestinal obstruction, or intussusception.
• Previous pathological intestinal inflammatory conditions such as inflammatory bowel disease.
• History of traumatic brain injury, cerebral palsy, encephalitis, or other organic brain disorders.
• Severe hepatic or renal insufficiency (defined as levels greater than three times the upper limit of normal).
• Pregnant or breastfeeding women.
• Use of medications such as probiotics or antibiotics that clearly affect the intestinal flora within 1 months prior to the visit or during the treatment.
• Any other reason that the investigator deems unsuitable for participation in this clinical trial.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

MeSH Terms

Conditions

Anorexia Nervosa

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Central Study Contacts

CHEN JUE

CONTACT

+8618017311203; chenjue2088@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: December 20, 2024
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 19, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share