ObesityNCT05002153
The Role of Microbiome in Recurrent Obesity
A study testing Fecal microbiota transplantation (FMT) in people with Obesity and Weight Loss, run by Assaf Harofeh MC.
Trial summary
This past century witnessed a significant increase in the prevalence of obesity, when since 1980 worldwide obesity has more than doubled. According to the World Health Organization, 39% of adults from the age of 18 years or older are overweight while 13% are obese. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Weight Loss, FMT
- What is being tested?
- Fecal microbiota transplantation (FMT)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Jan 2022to Dec 2024
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 28<BMI>35
- Age: 18-65
- Capable of working with a smartphone application
Who cannot join
- Consumption of antibiotics/probiotics/oral antifungals 3 months prior to the first day of the experiment.
- Pregnancy, fertility treatments, breastfeeding women six months prior to enrollment and during the study.
- Chronic disease (e.g. AIDS, Cushing syndrome, CKD, acromegaly, hyperthyroidism/hypothyroidism etc.)
- Cancer and recent anticancer treatment
- Psychiatric disorders
- Coagulation disorders
Show all 11Show fewer
- IBD (inflammatory bowel diseases)
- Bariatric surgery
- Eating disorders (Anorexia nervosa. Bulimia nervosa. Binge eating disorder, Night eating syndrome).
- Alcohol or substance abuse
- Weight loss attempts one year prior to the first day of the experiment - independent or with a dietitian.
Trial locations and contacts
No sites are listed yet.
About this study
This past century witnessed a significant increase in the prevalence of obesity, when since 1980 worldwide obesity has more than doubled. According to the World Health Organization, 39% of adults from the age of 18 years or older are overweight while 13% are obese. Successful maintenance of weight loss as losing at least 10% of the initial body weight and maintaining it for at least one year. However, keeping the low body weight is rarely maintained, as 80% of people who lost 10% of their body weight will return to their initial weight within a year. When weight loss is maintained for 2-5 years the chance of long term success was shown to dramatically increase.
Although there is no agreement as to what contributes to the recurrent weight regain phenomenon (also known as 'weight cycling' or 'yo-yo diet'), it is strongly associated with the risk of developing metabolic risk factors and their complications including heart disease and all-cause mortality.
Read more
Altering the gut microbiota is one method to treat disease states associated with gut bacteria. For instance, fecal microbiota transplant (FMT) or fecal bacteriotherapy, is the process of transferring stool from a healthy donor to another. The goal of FMT is to restore host health by increasing diversity and function of the gut microbiota. The main advantage of FMT over probiotics is its ability to transplant the entire gut microbiota and metabolites from the donor to the recipient.
Although numerous individual microbes have been identified as related to obesity, multiple studies suggest that loss of microbial diversity has a stronger impact on the development of metabolic dysfunction, this diversity may be restored by FMT.
This study will determine whether microbiome modulation might be a possible future target against recurrent obesity in humans, and whether orally administered FMT from a lean donor, post weight loss might be an effective intervention to prevent weight regain.
Read the detailed description
This is a placebo-controlled, double blinded interventional study evaluating high intensity oral fecal microbiota transplantation from lean healthy donors to prevent weight regain after a successful weight loss intervention. Volunteers will be recruited in the following ways: e-mail, and social media. Volunteers wishing to participate will be asked to complete a questionnaire regarding the aforementioned inclusion and exclusion criteria. Volunteers who qualify for the study will be invited to an introductory meeting at the Weizmann Institute of Science. The details of the experiment and potential risks or discomforts involved in it will be presented, after which the volunteers will sign informed consent forms. Volunteers will start the study and become active participants for a maximal duration of two years, depending on the weight loss process.
The study will comprise of four parts:
- Baseline - one week of profiling and screening.
- Nutritional intervention - weight loss intervention which will be based on Mediterranean hypocaloric diet restriction. Meetings will occur twice a month starting from the second week of the study for a three-month period.
- FMT/ Placebo intervention - 5 weekly cycles of high intensity lean donor FMT/placebo will be administered starting after reaching a weight loss of 5 to 10% of total body weight. Each cycle will consist of 10 capsules administered on two consecutive days (total 100 capsules)
- Follow-up meetings - total follow up of one year after FMT cycles. Meetings will occur every month for the first 3 months of the study, and every 3 months, Afterwards.
- Conditions
- Obesity, Weight Loss, FMT
- Being tested
- Fecal microbiota transplantation (FMT), Placebo
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal microbiota transplantation (FMT)Other
FMT is the process of transferring stool from a healthy donor to another.
PlaceboOther
Placebo capsules consist a combination of agarose in normal saline/glycerol (the same vehicle as in a FMT capsules)
| Study group | Role | What they receive |
|---|---|---|
| Fecal Microbiota Transplantation (FMT) | Experimental | FMT capsules administration - intervention arm Receives: Other: Fecal microbiota transplantation (FMT) |
| Placebo | Placebo comparator | Placebo capsules administration Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiome Profiling
Collection of stool, urine and oral samples for microbiome composition. 16S RNA analysis.
Measured: 1.5 years
Reaching Target Weight
Investigate the effect of FMT administration after reaching target weight (kg) on the recurrent weight regain phenomenon.
Measured: 1.5 years
Secondary outcomes (3)
Glycemic Response
Performing continuous glucose monitoring (CGM) and oral glucose tolerance test (OGTT)
Measured: 1.5 years
Metabolic Rate
RMR
Measured: 1.5 years
Substrate Utilization
measured by indirect calorimetry
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study startJan 2022 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf Harofeh MC
- Sponsor type
- Other government
- Collaborators
- Weizmann Institute of Science
- Responsible party
- Sponsor-investigator, Assaf Harofeh MC, Assaf-Harofeh Medical Center
- Investigators
- Ilan Youngster, Dr., Principal investigator, Asaf Harofe Medical Center, Be'er Yaacov, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05002153
- Sponsor's protocol ID
- 0215-19-ASF
- Status last verified
- Dec 2021
- First submitted
- 27 Jul 2021
- Last updated
- 28 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wing RR, Phelan S. Long-term weight loss maintenance. Am J Clin Nutr. 2005 Jul;82(1 Suppl):222S-225S. doi: 10.1093/ajcn/82.1.222S.
PubMed 16002825Mackie GM, Samocha-Bonet D, Tam CS. Does weight cycling promote obesity and metabolic risk factors? Obes Res Clin Pract. 2017 Mar-Apr;11(2):131-139. doi: 10.1016/j.orcp.2016.10.284. Epub 2016 Oct 20.
PubMed 27773644Wing RR, Hill JO. Successful weight loss maintenance. Annu Rev Nutr. 2001;21:323-41. doi: 10.1146/annurev.nutr.21.1.323.
PubMed 11375440Bangalore S, Fayyad R, Laskey R, DeMicco DA, Messerli FH, Waters DD. Body-Weight Fluctuations and Outcomes in Coronary Disease. N Engl J Med. 2017 Apr 6;376(14):1332-1340. doi: 10.1056/NEJMoa1606148.
PubMed 28379800Lee P, Yacyshyn BR, Yacyshyn MB. Gut microbiota and obesity: An opportunity to alter obesity through faecal microbiota transplant (FMT). Diabetes Obes Metab. 2019 Mar;21(3):479-490. doi: 10.1111/dom.13561. Epub 2018 Nov 20.
PubMed 30328245Thaiss CA, Itav S, Rothschild D, Meijer MT, Levy M, Moresi C, Dohnalova L, Braverman S, Rozin S, Malitsky S, Dori-Bachash M, Kuperman Y, Biton I, Gertler A, Harmelin A, Shapiro H, Halpern Z, Aharoni A, Segal E, Elinav E. Persistent microbiome alterations modulate the rate of post-dieting weight regain. Nature. 2016 Dec 22;540(7634):544-551. doi: 10.1038/nature20796. Epub 2016 Nov 24.
PubMed 27906159
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Microbiome in Recurrent Obesity
- ClinicalTrials.gov ID
- NCT05002153
- Acronym / sponsor ID
- 0215-19-ASF
- Conditions
- Obesity, Weight Loss, FMT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assaf Harofeh MCOther government
- Collaborators
- Weizmann Institute of Science
- Study start
- Jan 2022 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 12 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This past century witnessed a significant increase in the prevalence of obesity, when since 1980 worldwide obesity has more than doubled. According to the World Health Organization, 39% of adults from the age of 18 years or older are overweight while 13% are obese. Successful maintenance of weight loss as losing at least 10% of the initial body weight and maintaining it for at least one year. However, keeping the low body weight is rarely maintained, as 80% of people who lost 10% of their body weight will return to their initial weight within a year. When weight loss is maintained for 2-5 years the chance of long term success was shown to dramatically increase.
Although there is no agreement as to what contributes to the recurrent weight regain phenomenon (also known as 'weight cycling' or 'yo-yo diet'), it is strongly associated with the risk of developing metabolic risk factors and their complications including heart disease and all-cause mortality.
Altering the gut microbiota is one method to treat disease states associated with gut bacteria. For instance, fecal microbiota transplant (FMT) or fecal bacteriotherapy, is the process of transferring stool from a healthy donor to another. The goal of FMT is to restore host health by increasing diversity and function of the gut microbiota. The main advantage of FMT over probiotics is its ability to transplant the entire gut microbiota and metabolites from the donor to the recipient.
Although numerous individual microbes have been identified as related to obesity, multiple studies suggest that loss of microbial diversity has a stronger impact on the development of metabolic dysfunction, this diversity may be restored by FMT.
This study will determine whether microbiome modulation might be a possible future target against recurrent obesity in humans, and whether orally administered FMT from a lean donor, post weight loss might be an effective intervention to prevent weight regain.
Detailed description
This is a placebo-controlled, double blinded interventional study evaluating high intensity oral fecal microbiota transplantation from lean healthy donors to prevent weight regain after a successful weight loss intervention. Volunteers will be recruited in the following ways: e-mail, and social media. Volunteers wishing to participate will be asked to complete a questionnaire regarding the aforementioned inclusion and exclusion criteria. Volunteers who qualify for the study will be invited to an introductory meeting at the Weizmann Institute of Science. The details of the experiment and potential risks or discomforts involved in it will be presented, after which the volunteers will sign informed consent forms. Volunteers will start the study and become active participants for a maximal duration of two years, depending on the weight loss process.
The study will comprise of four parts:
- Baseline - one week of profiling and screening.
- Nutritional intervention - weight loss intervention which will be based on Mediterranean hypocaloric diet restriction. Meetings will occur twice a month starting from the second week of the study for a three-month period.
- FMT/ Placebo intervention - 5 weekly cycles of high intensity lean donor FMT/placebo will be administered starting after reaching a weight loss of 5 to 10% of total body weight. Each cycle will consist of 10 capsules administered on two consecutive days (total 100 capsules)
- Follow-up meetings - total follow up of one year after FMT cycles. Meetings will occur every month for the first 3 months of the study, and every 3 months, Afterwards.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fecal Microbiota Transplantation (FMT) | Experimental | Other: Fecal microbiota transplantation (FMT)FMT capsules administration - intervention arm |
| Placebo | Placebo comparator | Other: PlaceboPlacebo capsules administration |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 28<BMI>35
- Age: 18-65
- Capable of working with a smartphone application
Key exclusion criteria (11 listed)
- Consumption of antibiotics/probiotics/oral antifungals 3 months prior to the first day of the experiment.
- Pregnancy, fertility treatments, breastfeeding women six months prior to enrollment and during the study.
- Chronic disease (e.g. AIDS, Cushing syndrome, CKD, acromegaly, hyperthyroidism/hypothyroidism etc.)
- Cancer and recent anticancer treatment
- Psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal microbiota transplantation (FMT)FMT is the process of transferring stool from a healthy donor to another. | Other | Fecal Microbiota Transplantation (FMT) |
| PlaceboPlacebo capsules consist a combination of agarose in normal saline/glycerol (the same vehicle as in a FMT capsules) | Other | Placebo |
Primary outcome
Microbiome Profiling
Time frame: 1.5 years
Collection of stool, urine and oral samples for microbiome composition. 16S RNA analysis.
Reaching Target Weight
Time frame: 1.5 years
Investigate the effect of FMT administration after reaching target weight (kg) on the recurrent weight regain phenomenon.
3 secondary outcomes
Glycemic Response
Time frame: 1.5 years
Metabolic Rate
Time frame: 1.5 years
Substrate Utilization
Time frame: 1.5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2021.
- Background: PubMed 16002825Wing RR, Phelan S. Long-term weight loss maintenance. Am J Clin Nutr. 2005 Jul;82(1 Suppl):222S-225S. doi: 10.1093/ajcn/82.1.222S.
- Background: PubMed 27773644Mackie GM, Samocha-Bonet D, Tam CS. Does weight cycling promote obesity and metabolic risk factors? Obes Res Clin Pract. 2017 Mar-Apr;11(2):131-139. doi: 10.1016/j.orcp.2016.10.284. Epub 2016 Oct 20.
- Background: PubMed 11375440Wing RR, Hill JO. Successful weight loss maintenance. Annu Rev Nutr. 2001;21:323-41. doi: 10.1146/annurev.nutr.21.1.323.
- Background: PubMed 28379800Bangalore S, Fayyad R, Laskey R, DeMicco DA, Messerli FH, Waters DD. Body-Weight Fluctuations and Outcomes in Coronary Disease. N Engl J Med. 2017 Apr 6;376(14):1332-1340. doi: 10.1056/NEJMoa1606148.
- Background: PubMed 30328245Lee P, Yacyshyn BR, Yacyshyn MB. Gut microbiota and obesity: An opportunity to alter obesity through faecal microbiota transplant (FMT). Diabetes Obes Metab. 2019 Mar;21(3):479-490. doi: 10.1111/dom.13561. Epub 2018 Nov 20.
- Background: PubMed 27906159Thaiss CA, Itav S, Rothschild D, Meijer MT, Levy M, Moresi C, Dohnalova L, Braverman S, Rozin S, Malitsky S, Dori-Bachash M, Kuperman Y, Biton I, Gertler A, Harmelin A, Shapiro H, Halpern Z, Aharoni A, Segal E, Elinav E. Persistent microbiome alterations modulate the rate of post-dieting weight regain. Nature. 2016 Dec 22;540(7634):544-551. doi: 10.1038/nature20796. Epub 2016 Nov 24.
- World Health Organization. WHO Obesity and OverweightLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilan Youngster, Dr. principal investigator
Asaf Harofe Medical Center, Be'er Yaacov, Israel
Questions about this trial
What is this clinical trial studying?
A study testing Fecal microbiota transplantation (FMT) in people with Obesity and Weight Loss, run by Assaf Harofeh MC.
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 3 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 28 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ilan Youngster, Dr. (+972-506301191, youngsteri@asaf.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiome Profiling (time frame: 1.5 years). The study lists 2 primary outcomes in all. 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 NCT05002153, which also lists 6 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 28 Dec 2021.