Efficacy and Safety of Fecal Microbiota Transplantation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorGuangzhou First People's Hospital

About this trial

In recent years, researches illustrate that multifactorial diseases such as functional gastrointestinal disorders, autoimmune diseases, metabolic, behavioral and neurological diseases are associated with an abnormal microbiome structure-dysbiosis, which means the imbalance of the microbiome community. Fecal microbiota transplantation (FMT), the infusion of faeces from a healthy donor to the gastrointestinal tract of a recipient patient aiming to alter the intestine microbiota, is recommended to be performed in Clostridium difficile infection(CDI) as the most effective therapy. It also being used experimentally in the treatment of the disease states linked to dysbiosis of the intestinal microbiota. However, the efficacy and safety of FMT to treat the dysbiosis-associated diseases is still in its infancy. To further verify the indications above, more data is required to be collected through studies.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Irritable Bowel Syndrome

Ulcerative colitis

Crohn's disease

Constipation

Disqualifiers

Current pregnancy or breast-feeding;

Suffering from other severe diseases, including liver or kidney failure, heart failure, MODS, coma, cerebrovascular accident;

Known contraindication to all FMT infusion method such as nasoduodenal tube insertion, endoscopy, colonoscopy and enema;

Any conditions that may render the efficacy of FMT or at the discretion of the investigators.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fecal Microbiota Transplantation

    Procedure/Surgery

    Procedure: Fecal Microbiota Transplantation

Treatment groups

300 Participants
are divided into 40 treatment groups

40

Treatment groups

See each treatment group below.

Group A: Irritable Bowel SyndromeExperimental treatment 1 intervention
Group B: ConstipationExperimental treatment 1 intervention
Group C: Clostridium Difficile InfectionExperimental treatment 1 intervention
Group D: Functional DyspepsiaExperimental treatment 1 intervention
Group E: Parkinson's DiseaseExperimental treatment 1 intervention
Group F: Metabolic SyndromeExperimental treatment 1 intervention
Group G: Non-Alcoholic Fatty Liver DiseaseExperimental treatment 1 intervention
Group H: Autism Spectrum DisorderExperimental treatment 1 intervention
Group I: Radiation EnteritisExperimental treatment 1 intervention
Group J: Atopic DermatitisExperimental treatment 1 intervention
Group K: Food AllergicExperimental treatment 1 intervention
Group L: Graft-versus-Host DiseaseExperimental treatment 1 intervention
Group M: ObesityExperimental treatment 1 intervention
Group N: Diabetes mellitusExperimental treatment 1 intervention
Group O: Multi-Drug Resistant InfectionExperimental treatment 1 intervention
Group P: Hepatic EncephalopathyExperimental treatment 1 intervention
Group Q: Enteric DysbacteriosisExperimental treatment 1 intervention
Group R: Multiple SclerosisExperimental treatment 1 intervention
Group S: Pseudomembranous EnteritisExperimental treatment 1 intervention
Group T: Acute PancreatitisExperimental treatment 1 intervention
Group U: Chronic Fatigue SyndromeExperimental treatment 1 intervention
Group V: Acute-on-chronic Liver Failure with HBV InfectionExperimental treatment 1 intervention
Group W: Alcoholic Liver DiseaseExperimental treatment 1 intervention
Group X: AnorexiaExperimental treatment 1 intervention
Group Y: Decompensated CirrhosisExperimental treatment 1 intervention
Group Z: Henoch-Schonlein PurpuraExperimental treatment 1 intervention
Group [: Autoimmune Liver DiseaseExperimental treatment 1 intervention
Group \: Systemic Lupus ErythematosusExperimental treatment 1 intervention
Group ]: IgG4-Related DiseaseExperimental treatment 1 intervention
Group ^: Celiac DiseaseExperimental treatment 1 intervention
Group _: Protein-losing EnteropathyExperimental treatment 1 intervention
Group `: Asperger SyndromeExperimental treatment 1 intervention
Group a: Rheumatoid arthritisExperimental treatment 1 intervention
Group b: Ulcerative colitisExperimental treatment 1 intervention
Group c: Crohn's diseaseExperimental treatment 1 intervention
Group d: PsoriasisExperimental treatment 1 intervention
Group e: Ankylosing spondylitisExperimental treatment 1 intervention
Group f: Immune checkpoint inhibition-related colitisExperimental treatment 1 intervention
Group g: Autoimmune enteropathyExperimental treatment 1 intervention
Group h: Drug-induced diarrheaExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The efficacy of FMT in patients with gastrointestinal symptom will be assessed by the change of Gastrointestinal Symptom Rating Scale(GSRS).

Gastrointestinal Symptom Rating Scale(GSRS) is a measure of gastrointestinal symptom severity in five clusters (pain, bloating, constipation, diarrhea, and early satiety).The items are scored between 1 and 7, where 1 corresponds to "no discomfort at all" and 7 to "very severe discomfort" from the symptom. The participants will be asked to filled in the scale in several time points from baseline to 12 months after FMT.

Time frame
1 year

Secondary outcomes

1

Number of Participants With Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events(CTCAE) V4.0

Time frame
1 year

Other outcomes

1

Numbers of patients who have improvement in clinical symptoms (depends on each disease as stated in outcome)

Time frame
1 year

Sponsors and contacts

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