We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 5 for:    microbiota transplant diabetes | Recruiting Studies
Previous Study | Return to List | Next Study

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

This study is currently recruiting participants.
Verified April 2017 by Siew Chien NG, Chinese University of Hong Kong
Sponsor:
ClinicalTrials.gov Identifier:
NCT03127696
First Posted: April 25, 2017
Last Update Posted: April 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Siew Chien NG, Chinese University of Hong Kong
  Purpose
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. Furthermore, clinical trials are being conducted to evaluate its use for other conditions including inflammatory bowel disease, irritable bowel syndrome, diabetes mellitus, non-alcoholic steatohepatitis and hepatic encephalopathy. 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.

Condition Intervention
Type2 Diabetes Type 2 Diabetes Mellitus Obese Procedure: Fecal Microbiota Transplantation Behavioral: Lifestyle Modification Program Procedure: Sham

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised Placebo-controlled Study of Fecal Microbiota Transplant (FMT) to Impact Body Weight and Glycemic Control in Obese Subjects With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Siew Chien NG, Chinese University of Hong Kong:

Primary Outcome Measures:
  • Proportion of at least 5% reduction in weight [ Time Frame: 24 weeks ]
    Determine the proportion of at least 5% reduction in weight compared with baseline weight at week 24


Secondary Outcome Measures:
  • Proportion of subjects achieving at least 5% reduction in weight compared with baseline [ Time Frame: 52 weeks ]
    Proportion of subjects achieving at least 5% reduction in weight at 52 weeks

  • Changes in waist circumference at weeks 24 and 52 compared with baseline [ Time Frame: 24 week and 52 week ]
    Compare the change in waist circumference between different treatment arms

  • At least 5% decrease in waist to hip ratio [ Time Frame: 24 week and 52 week ]
    Compare the change in waist to hip ratio between different treatment arms

  • At least 5% decrease in total body weight [ Time Frame: 24 week and 52 week ]
    Compare the change in total body weight between different treatment arms

  • Changes in body weight to calculate body mass index (BMI) at weeks 24 and 52 compared with baseline [ Time Frame: 24 week and 52 week ]
    Compare the change in weight to calculate the BMI between different treatment arms

  • Changes in liver biochemistry [ Time Frame: 24 week and 52 week ]
    Compare the change in liver biochemistry between different treatment arms at weeks 24 and 52 compared with baseline

  • Changes in fasting glucose [ Time Frame: 24 week and 52 week ]
    Compare the change in fasting glucose between different treatment arms at weeks 24 and 52 compared with baseline

  • Changes in fasting lipids [ Time Frame: 24 week and 52 week ]
    Compare the change in fasting lipids between different treatment arms at weeks 24 and 52 compared with baseline

  • Changes in fasting insulin [ Time Frame: 24 week and 52 week ]
    Compare the change in fasting insulin between different treatment arms at weeks 24 and 52 compared with baseline

  • Changes in HbA1c [ Time Frame: 24 week and 52 week ]
    Compare the change in HbA1C between different treatment arms at weeks 24 and 52 compared with baseline

  • A 30% decrease in insulin resistance at weeks 24 compared with baseline [ Time Frame: 24 week ]
    Compare the change in insulin resistance between different treatment arms

  • Changes in liver stiffness to assess improvement of other metabolic disease weeks 24 compared with baseline [ Time Frame: 24 week ]
    Compare the change in liver stiffness between different treatment arms

  • Change in microbiome of stool before reverting to baseline [ Time Frame: weeks 4, 8, 12, 16, 20, 24 and 52 ]
    Compare the change in microbiome between different treatment arms

  • Duration of stool microbiome change before reverting to baseline [ Time Frame: weeks 4, 8, 12, 16, 20, 24 and 52 ]
    Duration of stool microbiome between different treatment arms


Estimated Enrollment: 60
Actual Study Start Date: April 26, 2017
Estimated Study Completion Date: September 30, 2018
Estimated Primary Completion Date: March 31, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FMT + Lifestyle Modification Program
Patient will receive both FMT infusion and lifestyle modification program
Procedure: Fecal Microbiota Transplantation
FMT solution will be infused into the distal duodenum or jejunum via OGD.
Behavioral: Lifestyle Modification Program
Dietitian will guide and correct subjects in terms of their dietary habits, physical activity patterns, and other lifestyle habits.
Experimental: Fecal Microbiota Transplantation
Patient will receive Fecal Microbiota Transplantation infusion only
Procedure: Fecal Microbiota Transplantation
FMT solution will be infused into the distal duodenum or jejunum via OGD.
Sham Comparator: Sham + Lifestyle Modification Program
Patient will receive infusion with normal saline and lifestyle modification program
Behavioral: Lifestyle Modification Program
Dietitian will guide and correct subjects in terms of their dietary habits, physical activity patterns, and other lifestyle habits.
Procedure: Sham
Normal saline will be infused into the distal duodenum or jejunum via OGD.

Detailed Description:

There is a worldwide epidemic of obesity and type 2 diabetes mellitus. The prevalence of obesity and type 2 diabetes mellitus continues to rise at an alarming rate. In China, more than 100 million people are estimated to suffer from diabetes. Similarly, the prevalence of overweight and obese individuals in China has increased by four-fold from 3.7% to 19.0% over two decades 1. Weight loss is associated with reductions in risk of morbidity and mortality from obesity. Conventional non-pharmacological interventions based on diet and exercise showed limited long-term success in producing sustained weight loss. Although obese patients with type 2 diabetes mellitus may be treated by medications or by bariatric surgery, these alternatives are limited by incomplete resolution of the diseases, high cost or potential surgical-related morbidity. Further research focusing on increasing effectiveness of interventions and new ways to achieve weight loss in these individuals are needed.

Recently, accumulating evidence supports a role of the enteric microbiota in the pathogenesis of obesity-related insulin resistance. Obesity is associated with changes in the composition of the intestinal microbiota, and the obese microbiome appears to be more efficient in harvesting energy from the diet. Colonization of germ-free mice with an 'obese microbiota' results in a significantly greater increase in total body fat than colonization with a 'lean microbiota', suggesting gut microbiota as an additional contributing factor to the pathophysiology of obesity. Obese and lean phenotypes can also be induced in germ-free mice by transfer of fecal microbiota from human donors. These data have led to the use of microbiota therapeutics as a potential treatment for metabolic syndrome and obesity.

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. Furthermore, clinical trials are being conducted to evaluate its use for other conditions including inflammatory bowel disease, irritable bowel syndrome, diabetes mellitus, non-alcoholic steatohepatitis and hepatic encephalopathy. 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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), malignant disease, inflammatory bowel disease, kidney failure, epilepsy, active infection, acquired immunodeficiency syndrome
  • Known contraindications to oesophago-gastro-duodenoscopy (OGD)
  • Use of probiotic or antibiotics in recent 3 months
  • Clinically significant abnormality on ECG at screening as judged by investigator
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03127696


Contacts
Contact: Amy LI +852 26373225 amyli@cuhk.edu.hk
Contact: Whitney TANG +852 35051519 whitneytang@cuhk.edu.hk

Locations
Hong Kong
The Chinese University of Hong Kong Recruiting
Sha Tin, Hong Kong, 000000
Contact: Siew Chien Ng, PhD    35053996    siewchienng@cuhk.edu.hk   
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Siew NG, Prof. Chinese University of Hong Kong
  More Information

Publications:
Ma RC, Lin X, Jia W. Causes of type 2 diabetes in China. Lancet Diabetes Endocrinol. 2014 Dec;2(12):980-91. doi: 10.1016/S2213-8587(14)70145-7. Epub 2014 Sep 10.
Haslam DW, James WP. Obesity. Lancet. 2005 Oct 1;366(9492):1197-209. Review.
Poobalan AS, Aucott LS, Smith WC, Avenell A, Jung R, Broom J. Long-term weight loss effects on all cause mortality in overweight/obese populations. Obes Rev. 2007 Nov;8(6):503-13. Review.
Dombrowski SU, Knittle K, Avenell A, Araújo-Soares V, Sniehotta FF. Long term maintenance of weight loss with non-surgical interventions in obese adults: systematic review and meta-analyses of randomised controlled trials. BMJ. 2014 May 14;348:g2646. doi: 10.1136/bmj.g2646. Review.
Turnbaugh PJ, Hamady M, Yatsunenko T, Cantarel BL, Duncan A, Ley RE, Sogin ML, Jones WJ, Roe BA, Affourtit JP, Egholm M, Henrissat B, Heath AC, Knight R, Gordon JI. A core gut microbiome in obese and lean twins. Nature. 2009 Jan 22;457(7228):480-4. doi: 10.1038/nature07540. Epub 2008 Nov 30.
Turnbaugh PJ, Ley RE, Mahowald MA, Magrini V, Mardis ER, Gordon JI. An obesity-associated gut microbiome with increased capacity for energy harvest. Nature. 2006 Dec 21;444(7122):1027-31.
Ridaura VK, Faith JJ, Rey FE, Cheng J, Duncan AE, Kau AL, Griffin NW, Lombard V, Henrissat B, Bain JR, Muehlbauer MJ, Ilkayeva O, Semenkovich CF, Funai K, Hayashi DK, Lyle BJ, Martini MC, Ursell LK, Clemente JC, Van Treuren W, Walters WA, Knight R, Newgard CB, Heath AC, Gordon JI. Gut microbiota from twins discordant for obesity modulate metabolism in mice. Science. 2013 Sep 6;341(6150):1241214. doi: 10.1126/science.1241214.
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.
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.
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.
Vrieze A, Van Nood E, Holleman F, Salojärvi 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. Erratum in: Gastroenterology. 2013 Jan;144(1):250.
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. Review.
Kassam Z, Lee CH, Yuan Y, Hunt RH. Fecal microbiota transplantation for Clostridium difficile infection: systematic review and meta-analysis. Am J Gastroenterol. 2013 Apr;108(4):500-8. doi: 10.1038/ajg.2013.59. Epub 2013 Mar 19. Review.
Wong SK, Kong AP, Mui WL, So WY, Tsung BY, Yau PY, Chow FC, Ng EK. Laparoscopic bariatric surgery: a five-year review. Hong Kong Med J. 2009 Apr;15(2):100-9.
Chan JC, So W, Ma RC, Tong PC, Wong R, Yang X. The Complexity of Vascular and Non-Vascular Complications of Diabetes: The Hong Kong Diabetes Registry. Curr Cardiovasc Risk Rep. 2011 Jun;5(3):230-239. Epub 2011 Apr 12.
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.
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. Review.

Responsible Party: Siew Chien NG, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03127696     History of Changes
Other Study ID Numbers: FMT-DM-RCT study
First Submitted: April 7, 2017
First Posted: April 25, 2017
Last Update Posted: April 28, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Siew Chien NG, Chinese University of Hong Kong:
Fecal Microbiota Transplant

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Body Weight
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Signs and Symptoms


To Top