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Type2 DiabetesNCT03127696

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

A study testing Fecal Microbiota Transplantation and Lifestyle Modification Program in people with Type2 Diabetes and Type 2 Diabetes Mellitus, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Type2 Diabetes, Type 2 Diabetes Mellitus, Obese
What is being tested?
Fecal Microbiota Transplantation and Lifestyle Modification Program
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
61 participants
Where
1 siteHong Kong
Study dates
26 Apr 2017to 6 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • The Chinese University of Hong Kong

    Shatin, 000000

Other trials in Hong Kong

About this study

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

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.

Read the 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. 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.

Clinical trials are being conducted to evaluate its use for other conditions. 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.

No clinical studies have assessed the efficacy of FMT in obese subjects with type 2 diabetes mellitus.

A subgroup of 30 subjects will be analyzed at week 24. The difference and proportion in microbiome in different arms, microbial factors, and trans-kingdom correlation of microbial engraftment will be correlated with clinical data in an unblinded manner.

Being tested
Fecal Microbiota Transplantation, Lifestyle Modification Program, Sham
Keywords
Fecal Microbiota Transplant
Medical subject headings
Diabetes Mellitus, Type 2, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fecal Microbiota TransplantationProcedure or surgery

    FMT

  • Lifestyle Modification ProgramBehavioural

    Lifestyle

  • ShamProcedure or surgery

    Sham

Study groups in NCT03127696
Study groupRoleWhat they receive
FMT + LMPExperimentalFMT and lifestyle modification program
Receives: Procedure: Fecal Microbiota Transplantation; Behavioral: Lifestyle Modification Program
FMT aloneExperimentalFecal Microbiota Transplantation
Receives: Procedure: Fecal Microbiota Transplantation
Sham + LMPSham comparatorSham and lifestyle modification program
Receives: Behavioral: Lifestyle Modification Program; Procedure: Sham

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 24 weeks

Secondary outcomes (15)

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

    Changes in microbial composition (including bacteriome and virome), function and metabolite at weeks 4, 16, 20 and 24 compared with baseline

    Measured: 4, 16, 20, 24 week

  2. Changes in microbiome of stool (including bacteriome and virome)

    Changes in microbiome of stool (including bacteriome and virome) at weeks 4, 16 and 24 compared with baseline

    Measured: 4, 16, 24 week

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

    Compare the difference in microbiome among different treatment arms

    Measured: 24 week and 52 week

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

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

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

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

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

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

  6. Microbial factors (including bacteriome and virome) that are associated with percentage of body weight loss

    Microbial factors (including bacteriome and virome) that are associated with percentage of body weight loss

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

  7. Trans-kingdom correlation of microbial engraftment

    Trans-kingdom correlation of microbial engraftment after FMT between bacteriome, and virome

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

  8. Proportion of subjects with serious adverse events compared between treatment arm, especially those related to FMT

    Proportion of subjects with serious adverse events compared between treatment arm, especially those related to FMT

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

  9. Explore changes in fungome microbiota

    Explore changes in fungome microbiota

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

  10. Proportion of subjects achieving at least 10% reduction in weight compared with baseline

    Proportion of subjects achieving at least 10% reduction in weight at 52 weeks

    Measured: 52 weeks

  11. Proportion of subjects achieving at least 10% reduction in weight compared with baseline

    Proportion of subjects achieving at least 10% reduction in weight at 24 weeks

    Measured: 24 weeks

  12. Changes in body weight to calculate body mass index (BMI) at weeks 24 and 52 compared with baseline

    Compare the change in weight to calculate the BMI among different treatment arms

    Measured: 24 week and 52 week

  13. Changes in biochemical parameters

    Changes in liver biochemistry, fasting glucose, fasting lipids, fasting insulin, HbA1C at weeks 24 and 52 compared with baseline

    Measured: 24 week and 52 week

  14. A 30% decrease in insulin resistance at weeks 24 compared with baseline

    A 30% decrease in insulin resistance at weeks 24 compared with baseline

    Measured: week 24

  15. Changes in liver stiffness to assess improvement of other metabolic disease weeks 24 compared with baseline

    Changes in liver stiffness to assess improvement of other metabolic disease weeks 24 compared with baseline

    Measured: week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2017
  2. Study start26 Apr 2017
  3. Primary completion15 May 2019
  4. Study completion6 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03127696
Sponsor's protocol ID
FMT-DM-RCT study
Status last verified
Feb 2022
First submitted
7 Apr 2017
Last updated
15 Feb 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 25218727

  • Haslam DW, James WP. Obesity. Lancet. 2005 Oct 1;366(9492):1197-209. doi: 10.1016/S0140-6736(05)67483-1.

    PubMed 16198769

  • 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. doi: 10.1111/j.1467-789X.2007.00393.x.

    PubMed 17949355

  • Dombrowski SU, Knittle K, Avenell A, Araujo-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.

    PubMed 25134100

  • 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.

    PubMed 19043404

  • 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. doi: 10.1038/nature05414.

    PubMed 17183312

  • 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.

    PubMed 24009397

  • 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.

    PubMed 23363771

  • 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.

    PubMed 23323867

  • 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.

    PubMed 25857665

  • 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.

    PubMed 22728514

  • 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.

    PubMed 25982290

  • 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.

    PubMed 23511459

  • 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.

    PubMed 19342735

  • 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. doi: 10.1007/s12170-011-0172-6. Epub 2011 Apr 12.

    PubMed 21654912

Questions about this trial

What is this clinical trial studying?

A study testing Fecal Microbiota Transplantation and Lifestyle Modification Program in people with Type2 Diabetes and Type 2 Diabetes Mellitus, run by Chinese University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03127696, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2022.

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