Randomised Placebo-controlled Study of FMT to Impact Body Weight and Glycemic Control in Obese Subjects With T2DM

NCT03127696 | Completed

• 1 other identifier: FMT-DM-RCT study
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

Faecal microbiota transplantation (FMT) represents a clinically feasible way to restore the gut microbial ecology, and has proven to be a breakthrough for the treatment of recurrent Clostridium difficile infection. Early results in human have shown that FMT from lean donor when transplanted into subjects with metabolic syndrome resulted in a significant improvement in insulin sensitivity and an increased in intestinal microbial diversity, including a distinct increase in butyrate-producing bacterial strains. The therapy is generally well tolerated and appeared safe. No clinical studies have assessed the efficacy of FMT in obese subjects with type 2 diabetes mellitus.

Conditions

Type2 Diabetes; Type 2 Diabetes Mellitus; Obese

Keywords

Fecal Microbiota Transplant

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects with at least 20% lean-associated microbiota in recipients after FMT compared with subjects receiving lifestyle intervention alone up to week 24

  Proportion of subjects with at least 20% lean-associated microbiota in recipients after FMT compared with subjects receiving lifestyle intervention alone up to week 24.

  24 weeks

Secondary Outcomes (15)

• Changes in microbial composition (including bacteriome and virome), function and metabolite

  4, 16, 20, 24 week

• Changes in microbiome of stool (including bacteriome and virome)

  4, 16, 24 week

• Difference in microbiome (including bacteriome and virome) compared between subjects in different treatment arm

  24 week and 52 week

• Proportion of microbiome (including bacteriome and virome) derived from recipient, donor or both in subjects who received FMT

  weeks 4, 8, 12, 16, 20, 24 and 52

• Difference in microbiome (including bacteriome and virome) compared between subjects who have weight loss and those do not have weight loss

  weeks 4, 8, 12, 16, 20, 24 and 52

Study Arms (3)

FMT + LMP

EXPERIMENTAL

FMT and lifestyle modification program

Procedure: Fecal Microbiota Transplantation; Behavioral: Lifestyle Modification Program

FMT alone

EXPERIMENTAL

Fecal Microbiota Transplantation

Procedure: Fecal Microbiota Transplantation

Sham + LMP

SHAM COMPARATOR

Sham and lifestyle modification program

Behavioral: Lifestyle Modification Program; Procedure: Sham

Interventions

Fecal Microbiota Transplantation PROCEDURE

FMT

FMT + LMP; FMT alone

Lifestyle Modification Program BEHAVIORAL

Lifestyle

FMT + LMP; Sham + LMP

Sham PROCEDURE

Sham

Sham + LMP

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70; and
• BMI \>=28 kg/m2 and \< 45 kg/m2; and
• A diagnosis of Type 2 diabetes mellitus for \>=3 months; and
• Written informed consent obtained

You may not qualify if:

• Current pregnancy
• Use of any weight loss medications in the preceding 1 year
• Known history or concomitant significant gastrointestinal disorders (including Inflammatory Bowel Disease, current colorectal cancer, current GI infection)
• Known history or concomitant significant food allergies
• Immunosuppressed subjects
• Known history of severe organ failure (including decompensated cirrhosis), inflammatory bowel disease, kidney failure, epilepsy, acquired immunodeficiency syndrome
• Current active sepsis
• Active malignant disease in recent 2 years
• Known contraindications to oesophago-gastro-duodenoscopy (OGD)
• Use of probiotic or antibiotics in recent 3 months

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Shatin, 000000, Hong Kong

Location

Related Publications (18)

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• Smith MI, Yatsunenko T, Manary MJ, Trehan I, Mkakosya R, Cheng J, Kau AL, Rich SS, Concannon P, Mychaleckyj JC, Liu J, Houpt E, Li JV, Holmes E, Nicholson J, Knights D, Ursell LK, Knight R, Gordon JI. Gut microbiomes of Malawian twin pairs discordant for kwashiorkor. Science. 2013 Feb 1;339(6119):548-54. doi: 10.1126/science.1229000. Epub 2013 Jan 30.

  PMID: 23363771 BACKGROUND

• van Nood E, Vrieze A, Nieuwdorp M, Fuentes S, Zoetendal EG, de Vos WM, Visser CE, Kuijper EJ, Bartelsman JF, Tijssen JG, Speelman P, Dijkgraaf MG, Keller JJ. Duodenal infusion of donor feces for recurrent Clostridium difficile. N Engl J Med. 2013 Jan 31;368(5):407-15. doi: 10.1056/NEJMoa1205037. Epub 2013 Jan 16.

  PMID: 23323867 BACKGROUND

• Moayyedi P, Surette MG, Kim PT, Libertucci J, Wolfe M, Onischi C, Armstrong D, Marshall JK, Kassam Z, Reinisch W, Lee CH. Fecal Microbiota Transplantation Induces Remission in Patients With Active Ulcerative Colitis in a Randomized Controlled Trial. Gastroenterology. 2015 Jul;149(1):102-109.e6. doi: 10.1053/j.gastro.2015.04.001. Epub 2015 Apr 7.

  PMID: 25857665 BACKGROUND

• Vrieze A, Van Nood E, Holleman F, Salojarvi J, Kootte RS, Bartelsman JF, Dallinga-Thie GM, Ackermans MT, Serlie MJ, Oozeer R, Derrien M, Druesne A, Van Hylckama Vlieg JE, Bloks VW, Groen AK, Heilig HG, Zoetendal EG, Stroes ES, de Vos WM, Hoekstra JB, Nieuwdorp M. Transfer of intestinal microbiota from lean donors increases insulin sensitivity in individuals with metabolic syndrome. Gastroenterology. 2012 Oct;143(4):913-6.e7. doi: 10.1053/j.gastro.2012.06.031. Epub 2012 Jun 20.

  PMID: 22728514 BACKGROUND

• Kelly CR, Kahn S, Kashyap P, Laine L, Rubin D, Atreja A, Moore T, Wu G. Update on Fecal Microbiota Transplantation 2015: Indications, Methodologies, Mechanisms, and Outlook. Gastroenterology. 2015 Jul;149(1):223-37. doi: 10.1053/j.gastro.2015.05.008. Epub 2015 May 15.

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• Wong VW, Chan RS, Wong GL, Cheung BH, Chu WC, Yeung DK, Chim AM, Lai JW, Li LS, Sea MM, Chan FK, Sung JJ, Woo J, Chan HL. Community-based lifestyle modification programme for non-alcoholic fatty liver disease: a randomized controlled trial. J Hepatol. 2013 Sep;59(3):536-42. doi: 10.1016/j.jhep.2013.04.013. Epub 2013 Apr 23.

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• Wang S, Xu M, Wang W, Cao X, Piao M, Khan S, Yan F, Cao H, Wang B. Systematic Review: Adverse Events of Fecal Microbiota Transplantation. PLoS One. 2016 Aug 16;11(8):e0161174. doi: 10.1371/journal.pone.0161174. eCollection 2016.

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• Ng SC, Xu Z, Mak JWY, Yang K, Liu Q, Zuo T, Tang W, Lau L, Lui RN, Wong SH, Tse YK, Li AYL, Cheung K, Ching JYL, Wong VWS, Kong APS, Ma RCW, Chow EYK, Wong SKH, Ho ICH, Chan PKS, Chan FKL. Microbiota engraftment after faecal microbiota transplantation in obese subjects with type 2 diabetes: a 24-week, double-blind, randomised controlled trial. Gut. 2022 Apr;71(4):716-723. doi: 10.1136/gutjnl-2020-323617. Epub 2021 Mar 30.

  PMID: 33785557 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Interventions

Fecal Microbiota Transplantation; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Siew NG, Prof.

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 7, 2017
• First Posted: April 25, 2017
• Study Start: April 26, 2017
• Primary Completion: May 15, 2019
• Study Completion: December 6, 2019
• Last Updated: February 15, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)