Fecal Microbiota Transplant (FMT) to Induce Weight Loss in Obese Subjects
Primary Purpose
Obesity
Status
Active
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Fecal Microbiota Transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Fecal Microbiota Transplantation, FMT
Eligibility Criteria
Inclusion Criteria:
- Age 18-75; and
- BMI ≥28 kg/m^2 and < 45 kg/m^2; and
- Written informed consent obtained
Exclusion Criteria:
- Current pregnancy
- Known history or concomitant significant gastrointestinal disorders (including Inflammatory Bowel Disease, current colorectal cancer)
- Known history or concomitant significant food allergies
- Immunosuppressed subjects
- Known history of severe organ failure (including decompensated cirrhosis), kidney failure, epilepsy, acquired immunodeficiency syndrome
- Current active sepsis
- Known contraindications to oesophago-gastro-duodenoscopy (OGD)
- Use of probiotic or antibiotics in recent 3 months
- New drugs in the last three months that can impact on metabolism or body weight
- Previous gastric or small intestinal surgery that alters gut anatomy such as fundoplication, gastric resection, gastric bypass, small bowel resection, ileoectomy, colectomy
- Patients who have a confirmed current active malignancy or cancer
Sites / Locations
- The Chinese University of Hong Kong
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Fecal Microbiota Transplantation
Arm Description
FMT infusion
Outcomes
Primary Outcome Measures
Proportion of at least 10% reduction in weight
Determine the proportion of at least 10% reduction in weight compared with baseline weight
Secondary Outcome Measures
Proportion of subjects maintaining weight reduction
Proportion of subjects maintaining at least 10% reduction in weight compared with baseline
Proportion of subjects maintaining weight reduction
Proportion of subjects maintaining at least 5% reduction in weight compared with baseline
Changes in waist circumference
Changes in waist circumference compared with baseline
Decrease in waist to hip ratio and in total body weight
At least 5% decrease in waist to hip ratio and in total body weight
Change in biochemical parameters
Study samples will collected to characterize which microbiota favors FMT by performing metagenomics of gut microbiome in stool samples
Full Information
NCT ID
NCT03789461
First Posted
December 24, 2018
Last Updated
February 10, 2022
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT03789461
Brief Title
Fecal Microbiota Transplant (FMT) to Induce Weight Loss in Obese Subjects
Official Title
An Open-label Pilot Study of Fecal Microbiota Transplant (FMT) to Induce Weight Loss in Obese Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 28, 2018 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
Fecal 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.
The therapy is generally well tolerated and appeared safe. No clinical studies have assessed the dosage of FMT in obese subjects.
Detailed Description
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.
Fecal 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 dosage of FMT in obese subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Fecal Microbiota Transplantation, FMT
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fecal Microbiota Transplantation
Arm Type
Experimental
Arm Description
FMT infusion
Intervention Type
Procedure
Intervention Name(s)
Fecal Microbiota Transplantation
Intervention Description
FMT infusion (100-200ml) and Mucosal Microbiota Assessment (To assess the fecal and mucosal microbiota before and after FMT)
Primary Outcome Measure Information:
Title
Proportion of at least 10% reduction in weight
Description
Determine the proportion of at least 10% reduction in weight compared with baseline weight
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Proportion of subjects maintaining weight reduction
Description
Proportion of subjects maintaining at least 10% reduction in weight compared with baseline
Time Frame
12, 26, 52, 78, 104 weeks
Title
Proportion of subjects maintaining weight reduction
Description
Proportion of subjects maintaining at least 5% reduction in weight compared with baseline
Time Frame
6,12, 26, 52, 78, 104 weeks
Title
Changes in waist circumference
Description
Changes in waist circumference compared with baseline
Time Frame
6,12, 26, 52, 78, 104 weeks
Title
Decrease in waist to hip ratio and in total body weight
Description
At least 5% decrease in waist to hip ratio and in total body weight
Time Frame
6,12, 26, 52, 78, 104 weeks
Title
Change in biochemical parameters
Description
Study samples will collected to characterize which microbiota favors FMT by performing metagenomics of gut microbiome in stool samples
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18-75; and
BMI ≥28 kg/m^2 and < 45 kg/m^2; and
Written informed consent obtained
Exclusion Criteria:
Current pregnancy
Known history or concomitant significant gastrointestinal disorders (including Inflammatory Bowel Disease, current colorectal cancer)
Known history or concomitant significant food allergies
Immunosuppressed subjects
Known history of severe organ failure (including decompensated cirrhosis), kidney failure, epilepsy, acquired immunodeficiency syndrome
Current active sepsis
Known contraindications to oesophago-gastro-duodenoscopy (OGD)
Use of probiotic or antibiotics in recent 3 months
New drugs in the last three months that can impact on metabolism or body weight
Previous gastric or small intestinal surgery that alters gut anatomy such as fundoplication, gastric resection, gastric bypass, small bowel resection, ileoectomy, colectomy
Patients who have a confirmed current active malignancy or cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Siew NG, Prof.
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Citations:
PubMed Identifier
19043404
Citation
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.
Results Reference
background
PubMed Identifier
17183312
Citation
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.
Results Reference
background
PubMed Identifier
24009397
Citation
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.
Results Reference
background
PubMed Identifier
23363771
Citation
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.
Results Reference
background
PubMed Identifier
23323867
Citation
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.
Results Reference
background
PubMed Identifier
25857665
Citation
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.
Results Reference
background
PubMed Identifier
22728514
Citation
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. Erratum In: Gastroenterology. 2013 Jan;144(1):250.
Results Reference
background
PubMed Identifier
25982290
Citation
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.
Results Reference
background
PubMed Identifier
23511459
Citation
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.
Results Reference
background
PubMed Identifier
19342735
Citation
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.
Results Reference
background
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Fecal Microbiota Transplant (FMT) to Induce Weight Loss in Obese Subjects
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