Obesity, MorbidRCTFMTObNCT03273855
Randomized Controlled Trial of Fecal Microbiota Transplantation in Severe Obesity
A study testing Fecal microbiota transplantation in people with Obesity, Morbid, run by University Hospital of North Norway at 1 site in Norway.
Trial summary
This is a randomized, double-blinded and placebo controlled prospective trial with sixty patients to investigate the effect of fecal microbiota transplantation (FMT) on body weight in patients with severe obesity. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Obesity, Morbid
- What is being tested?
- Fecal microbiota transplantation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- 13 May 2019to 1 May 2023
- 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 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI > 40 or BMI > 35 kg/m2 combined with comorbidity related to obesity.
Who cannot join
- Symptomatic cardiovascular disease, lung disease, cirrhosis or significant renal failure.
- Patients who are pregnant or breastfeeding
- Patients who have a confirmed malignancy or cancer
- Patients who are immunocompromised
- Previous gastric or small intestinal surgery that alters gut anatomy such as fundoplication, gastric resection, gastric bypass, small bowel resection, and ileoectomy
- Established drug- or alcohol abuse or particularly unstable psychosocial circumstances.
Show all 9Show fewer
- History of cholecystektomy (gut microbiota composition could be affected by bile acid composition)
- New drugs the last three months or during the follow-up period that can impact on metabolism or body weight
- Antibiotic treatment the last three months
Trial locations and contacts
1 site in 1 country.
About this study
This is a randomized, double-blinded and placebo controlled prospective trial with sixty patients to investigate the effect of fecal microbiota transplantation (FMT) on body weight in patients with severe obesity. We will also collect data that possibly could give a better understanding of mechanisms of this correlation.
Read the detailed description
Obesity is a main threat to public health in western countries. This condition increases the risk of developing type 2 diabetes, cardiovascular diseases, physical stress disorders, dispose for cancer and contributes to increased overall morbidity and mortality. However sustained weight loss lead to the reduction of risk factors and improvement of several obesity related co-morbidities.
Currently there are mainly two established treatments for severe obesity: a conservative approach through lifestyle intervention and a surgical approach with bariatric surgery. The gut microbiota is recognized as an environmental modulator of nutritional uptake and body weight. This has led to the hypothesis that the gut microbiota could be a therapeutic target fighting obesity. Fecal microbiota transplantation (FMT) has been applied for more than 50 years, and is a established treatment for refractory recurrent infection with Clostridium Difficile (CDI). Recent scientific studies have also applied FMT as treatment for other diseases like inflammatory bowel disease, irritable bowel disease and even metabolic syndrome and the results are promising.
The sample size is determined based on data from the outpatient clinic at UNN Harstad medical department. Patients here have an average weight loss of 2,5 % with conservative treatment. This will therefore be the expected result in the control group (receiving placebo). A weight reduction of 5-10% leads to significant improvement of health and quality of life, and a weight change of this magnitude is therefore the hypothesis. The difference between the two groups is estimated to 7,5 %. With these historical results, the sample size is estimated to be 19 patients in each group. Extreme values will be eliminated; more than 3 SD out of the average in the group. In this patient group, we must also be prepared to high degree loss of follow-up near one third, which is also the experience from the clinic. We will include totally 60 patients, 30 in each group.
The investigators are planning a randomized, double-blinded and placebo controlled prospective trial with sixty patients to investigate the effect of fecal microbiota transplantation (FMT) on body weight in patients with severe obesity. In the trial there will also be collected data that possibly could give a better understanding of mechanisms of this correlation; with insulin resistance, blood pressure, complete body scan, inflammation and biochemical parameters of hepatic steatosis, changes in the patients microbiota and the development in quality of life as secondary outcome measures.
- Conditions
- Obesity, Morbid
- Being tested
- Fecal microbiota transplantation, Placebo: fecal microbiota transplantation
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal microbiota transplantationOther
The intervention treatment is fecal microbiota transplantation made of frozen donor feces. The FMT is transferred as rectal enema where we use a rectal probe with a balloon to prevent leakage and keep the solution long enough in the colon. The patient will stay on the bench in different positions for 20 minutes. We will encourage the participant to keep the solution in the colon as long as possible and give them four pills of loperamide before the procedure in order to reduce bowel motility.
Placebo: fecal microbiota transplantationOther
The placebo group get fecal microbiota transplantation made of their own feces. The FMT is transferred as rectal enema where we use a rectal probe with a balloon to prevent leakage and keep the solution long enough in the colon. The patient will stay on the bench in different positions for 20 minutes. We will encourage the participant to keep the solution in the colon as long as possible and give them four pills of loperamide before the procedure in order to reduce bowel motility.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Active Comparator. Transplant from Donor A or Donor B, or Donor C or Donore D, one transplant consist of 50-80g of feacal matter. Receives: Other: Fecal microbiota transplantation |
| Placebo | Placebo comparator | Placebo. Patient will recieve an autologous fecal microbiota transplantation. Receives: Other: Placebo: fecal microbiota transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in individual weight loss (kg).
Partisipants will be measured at the outpatient clinic, medical department UNN Harstad, and weight in kilograms (kg) will be recorded. The data will be represented both as average weight change and as bar charts with >10%, with comparison between the intervention and control group.
Chi Square or Fischer exact test will be used to present responders and non-responders in the active and controll group. We will use odds ratio to present responders in the active group.
Measured: Change from baseline body weight at 12 months post FMT
Secondary outcomes (20)
Change in individual weight loss (kg)
Partisipants will be measured at the outpatient clinic, medical department UNN Harstad, and weight in kilograms (kg) will be recorded. The data will be represented both as average weight change and as bar charts with >5%, >15% and >20% weight loss, with comparison between the intervention and control group at each controll point.
Chi Square or Fischer exact test will be used to present responders and non-responders in the active and controll group. We will use odds ratio to present responders in the active group.
Measured: Change from baseline body weight at 3, 6 and 12 months after FMT
Change in waist circumference (cm)
Participants will be measured at the outpatient clinic, medical department UNN Harstad, and waist circumference (cm) will be recorded.
Measured: Change from baseline waist circumferense at 3, 6 and 12 months after FMT
Changes in HbA1c (mmol/mol)
Together with C-peptide, fasting glucose and insuline it will be used to research insuline resistance.
Measured: Change from baseline HbA1c at 3, 6 and 12 months after FMT
Changes in fasting glucose (mmol/L)
Together with HbA1c, C-peptide, and insuline it will be used to research insuline resistance and calculate HOMA-IR and HOMA-B
Measured: Change from baseline fasting glucose at 3, 6 and 12 months after FMT
Changes in insuline (pmol/L)
Together with HbA1c, C-peptide, and fasting glucose it will be used to research insuline resistance and calculate HOMA-IR and HOMA-B
Measured: Change from baseline insuline at 3, 6 and 12 months after FMT
Changes in C-peptide (pmol/L)
Together with HbA1c, fasting glucose and insuline it will be used to research insuline resistance.
Measured: Change from baseline C-peptide at 3, 6 and 12 months after FMT
Change in blood pressure
Participants blood pressure (mmHg) will be measured at the outpatient clinic, medical department UNN Harstad. Blood pressure is collected as the average of the last two out of three measurements, at the end of 5 min resting period in supine position.
Measured: Change from baseline blood pressure at 3, 6 and 12 months after FMT
Change in sedimentation rate (mm/t)
We will measure sedimentation rate, and together with hs-CRP and cytokine panel we will investigate inflamation between the group recieving placebo and the group recieving active transplant.
Measured: Change from baseline sedimentation rate at 3, 6 and 12 months after FMT
Change in hs-CRP (mg/L)
We will measure hs-CRP, and together with sedimentation rate and cytokine panel we will investigate inflamation between the group recieving placebo and the group recieving active transplant.
Measured: Change from baseline hs-CRP at 3, 6 and 12 months after FMT
Changes in multiplex cytokine panel (pg/mL)
We will run a multiplex cytokinepanel consiting of 27 different cytokines to see if the consentration of blood cytokines changes in participants after active treatment/placebo. The cytokine panel consists of TNF-a, IFN-g, IL-1b, IL-1ra, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12(p70), IL-13, IL-15, IL-17A, MCP-1(MCAF), IP-10, Eotaxin, MIP-1a, MIP-1b, RANTES, G-CSF, GM-CSF, Basic FGF, PDGF-BB, VEGF.
Measured: Change from baseline cytokine panel at 3, 6 and 12 months after FMT
Changes in biochemical parameters of hepatic steatosis (U/L)
Photometric analysis. We will measue AST, ALT, ALP, ɣGT and amylase to look at changes in biochemical parameters of hepatic steatosis between the group recieving placebo and the group recieving active transplant
Measured: Change from baseline biochemical parameters at 3, 6 and 12 months after FMT
Changes in lipid profile based on HDL/LDL (mmol/L) and cholesterol (mmol/L)
Photometric analysis. Changes in cholesterol and HDL/LDL be used to look at changes in lipid profile between the group recieving placebo and the group recieving active transplant
Measured: Change from baseline lipid profile at 3, 6 and 12 months afterFMT
Changes in life quality measured using RAND-36 questionnaire
RAND-36- Item Short Form Health Survey. The SF-36 consists of eight scaled scores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health), which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. By an independent sample T-test (or, if necessary, non-parametric Mann-Whitney) we will compare change in global score. We will apply last value forward for missing values
Measured: Change from baseline RAND-36 score 12 months after FMT
Changes in psychiatric comorbidity measured by HSCL-25
HSCL-25. Consists of 25 questions. Each answer to a question has a value of 1-4. A total score over 1,75 points to psychological issues or impaired mental health
Measured: Change from baseline HSCL-25 score 12 months after FMT
Changes in dietary intake measured by FFQ
FFQ Change in dietary intakes measured using Food Frequency Questionnaire at baseline and at 3, 6 and 12 months after FMT will be examined.
Energy measured as kcal, nutrition (gram) and different food groups reported as gram/day
Measured: Change from baseline FFQ score at 3, 6 and 12 months after FMT
Changes in life style measured by IPAQ
IPAQ Categorical Score
Three levels (categories) of physical activity are proposed:
Category 1: Low This is the lowest level of physical activity. Those individuals who not meet criteria for categories 2 or 3 are considered low/inactive.
Category 2: Moderate
Any one of the following 3 criteria:
- 3 or more days of vigorous activity of at least 20 minutes per day OR
- 5 or more days of moderate-intensity activity or walking of at least 30 minutes per day OR
- 5 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum of at least 600 MET-min/week.
Category 3: High
Any one of the following 2 criteria:
- Vigorous-intensity activity on at least 3 days and accumulating at least 1500 MET-minutes/ week OR
- 7 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum of at least 3000 MET-minutes/week
Measured: Change from baseline IPAQ score at 3, 6 and 12 months after FMT
Gut microbiota composition and function
Microbiota analysis and SCFA in faeces
Measured: Change from baseline microbiota composition at 3, 6 and 12 months after FMT
Short difficult childhood questionnaire
Questions of childhood trauma, four or six questions
Measured: At baseling
Childhood trauma Questionnaire (CTQ)
A validated questionnaire to collect self-reported data about adverse childhood experiences
Measured: Once during the follow up period in the study
Heart rate variability (HRV)
A dysbiotic gut microbiota that signals with the vagal nerve can cause an exaggerated stress response in obesity characterised by decrease in heart rate variability.
Measured: HRV will be measured at inclusion and 3.months post FMT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study start13 May 2019
- Primary completion1 May 2023 (estimated)
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity, MorbidStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology, Lovisenberg Diakonale Hospital, Nordlandssykehuset HF, Helse Nord, University of Tromso, Norwegian University of Life Sciences, University of Oslo
- Responsible party
- Sponsor
- Investigators
- Per C Valle, PhD, Principal investigator, University Hospital of North of NorwayMaria S Fjellstad, cand.med, Study chair, University Hospital of North of NorwayHege M Hanssen, M.Sc, Study chair, University Hospital of North Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03273855
- Sponsor's protocol ID
- 2017/1655
- Acronym
- RCTFMTOb
- Status last verified
- Jan 2023
- First submitted
- 31 Aug 2017
- Last updated
- 20 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hanssen HM, Fjellstad MS, Skjevling L, Johnsen PH, Kulseng B, Goll R, Alma KH, Valle PC. Randomised, placebo-controlled, double-blinded trial of fecal microbiota transplantation in severe obesity: a study protocol. BMJ Open. 2023 Dec 27;13(12):e073242. doi: 10.1136/bmjopen-2023-073242.
PubMed 38151280
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Fecal Microbiota Transplantation in Severe Obesity
- ClinicalTrials.gov ID
- NCT03273855
- Acronym / sponsor ID
- RCTFMTOb / 2017/1655
- Conditions
- Obesity, Morbid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology, Lovisenberg Diakonale Hospital, Nordlandssykehuset HF, Helse Nord, University of Tromso, Norwegian University of Life Sciences, University of Oslo
- Study start
- 13 May 2019 (actual)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 6 Sep 2017 (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 is a randomized, double-blinded and placebo controlled prospective trial with sixty patients to investigate the effect of fecal microbiota transplantation (FMT) on body weight in patients with severe obesity. We will also collect data that possibly could give a better understanding of mechanisms of this correlation.
Detailed description
Obesity is a main threat to public health in western countries. This condition increases the risk of developing type 2 diabetes, cardiovascular diseases, physical stress disorders, dispose for cancer and contributes to increased overall morbidity and mortality. However sustained weight loss lead to the reduction of risk factors and improvement of several obesity related co-morbidities.
Currently there are mainly two established treatments for severe obesity: a conservative approach through lifestyle intervention and a surgical approach with bariatric surgery. The gut microbiota is recognized as an environmental modulator of nutritional uptake and body weight. This has led to the hypothesis that the gut microbiota could be a therapeutic target fighting obesity. Fecal microbiota transplantation (FMT) has been applied for more than 50 years, and is a established treatment for refractory recurrent infection with Clostridium Difficile (CDI). Recent scientific studies have also applied FMT as treatment for other diseases like inflammatory bowel disease, irritable bowel disease and even metabolic syndrome and the results are promising.
The sample size is determined based on data from the outpatient clinic at UNN Harstad medical department. Patients here have an average weight loss of 2,5 % with conservative treatment. This will therefore be the expected result in the control group (receiving placebo). A weight reduction of 5-10% leads to significant improvement of health and quality of life, and a weight change of this magnitude is therefore the hypothesis. The difference between the two groups is estimated to 7,5 %. With these historical results, the sample size is estimated to be 19 patients in each group. Extreme values will be eliminated; more than 3 SD out of the average in the group. In this patient group, we must also be prepared to high degree loss of follow-up near one third, which is also the experience from the clinic. We will include totally 60 patients, 30 in each group.
The investigators are planning a randomized, double-blinded and placebo controlled prospective trial with sixty patients to investigate the effect of fecal microbiota transplantation (FMT) on body weight in patients with severe obesity. In the trial there will also be collected data that possibly could give a better understanding of mechanisms of this correlation; with insulin resistance, blood pressure, complete body scan, inflammation and biochemical parameters of hepatic steatosis, changes in the patients microbiota and the development in quality of life as secondary outcome measures.
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 |
|---|---|---|
| Intervention | Active comparator | Other: Fecal microbiota transplantationActive Comparator. Transplant from Donor A or Donor B, or Donor C or Donore D, one transplant consist of 50-80g of feacal matter. |
| Placebo | Placebo comparator | Other: Placebo: fecal microbiota transplantationPlacebo. Patient will recieve an autologous fecal microbiota transplantation. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI > 40 or BMI > 35 kg/m2 combined with comorbidity related to obesity.
Key exclusion criteria (9 listed)
- Symptomatic cardiovascular disease, lung disease, cirrhosis or significant renal failure.
- Patients who are pregnant or breastfeeding
- Patients who have a confirmed malignancy or cancer
- Patients who are immunocompromised
- Previous gastric or small intestinal surgery that alters gut anatomy such as fundoplication, gastric resection, gastric bypass, small bowel resection, and ileoectomy
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 transplantationThe intervention treatment is fecal microbiota transplantation made of frozen donor feces. The FMT is transferred as rectal enema where we use a rectal probe with a balloon to prevent leakage and keep the solution long enough in the colon. The patient will stay on the bench in different positions for 20 minutes. We will encourage the participant to keep the solution in the colon as long as possible and give them four pills of loperamide before the procedure in order to reduce bowel motility. | Other | Intervention |
| Placebo: fecal microbiota transplantationThe placebo group get fecal microbiota transplantation made of their own feces. The FMT is transferred as rectal enema where we use a rectal probe with a balloon to prevent leakage and keep the solution long enough in the colon. The patient will stay on the bench in different positions for 20 minutes. We will encourage the participant to keep the solution in the colon as long as possible and give them four pills of loperamide before the procedure in order to reduce bowel motility. | Other | Placebo |
Primary outcome
Change in individual weight loss (kg).
Time frame: Change from baseline body weight at 12 months post FMT
Partisipants will be measured at the outpatient clinic, medical department UNN Harstad, and weight in kilograms (kg) will be recorded. The data will be represented both as average weight change and as bar charts with >10%, with comparison between the intervention and control group. Chi Square or Fischer exact test will be used to present responders and non-responders in the active and controll group. We will use odds ratio to present responders in the active group.
20 secondary outcomes
Change in individual weight loss (kg)
Time frame: Change from baseline body weight at 3, 6 and 12 months after FMT
Change in waist circumference (cm)
Time frame: Change from baseline waist circumferense at 3, 6 and 12 months after FMT
Changes in HbA1c (mmol/mol)
Time frame: Change from baseline HbA1c at 3, 6 and 12 months after FMT
Changes in fasting glucose (mmol/L)
Time frame: Change from baseline fasting glucose at 3, 6 and 12 months after FMT
Changes in insuline (pmol/L)
Time frame: Change from baseline insuline at 3, 6 and 12 months after FMT
Changes in C-peptide (pmol/L)
Time frame: Change from baseline C-peptide at 3, 6 and 12 months after FMT
Change in blood pressure
Time frame: Change from baseline blood pressure at 3, 6 and 12 months after FMT
Change in sedimentation rate (mm/t)
Time frame: Change from baseline sedimentation rate at 3, 6 and 12 months after FMT
Change in hs-CRP (mg/L)
Time frame: Change from baseline hs-CRP at 3, 6 and 12 months after FMT
Changes in multiplex cytokine panel (pg/mL)
Time frame: Change from baseline cytokine panel at 3, 6 and 12 months after FMT
Changes in biochemical parameters of hepatic steatosis (U/L)
Time frame: Change from baseline biochemical parameters at 3, 6 and 12 months after FMT
Changes in lipid profile based on HDL/LDL (mmol/L) and cholesterol (mmol/L)
Time frame: Change from baseline lipid profile at 3, 6 and 12 months afterFMT
Changes in life quality measured using RAND-36 questionnaire
Time frame: Change from baseline RAND-36 score 12 months after FMT
Changes in psychiatric comorbidity measured by HSCL-25
Time frame: Change from baseline HSCL-25 score 12 months after FMT
Changes in dietary intake measured by FFQ
Time frame: Change from baseline FFQ score at 3, 6 and 12 months after FMT
Changes in life style measured by IPAQ
Time frame: Change from baseline IPAQ score at 3, 6 and 12 months after FMT
Gut microbiota composition and function
Time frame: Change from baseline microbiota composition at 3, 6 and 12 months after FMT
Short difficult childhood questionnaire
Time frame: At baseling
Childhood trauma Questionnaire (CTQ)
Time frame: Once during the follow up period in the study
Heart rate variability (HRV)
Time frame: HRV will be measured at inclusion and 3.months post FMT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
- Derived from this study: PubMed 38151280Hanssen HM, Fjellstad MS, Skjevling L, Johnsen PH, Kulseng B, Goll R, Alma KH, Valle PC. Randomised, placebo-controlled, double-blinded trial of fecal microbiota transplantation in severe obesity: a study protocol. BMJ Open. 2023 Dec 27;13(12):e073242. doi: 10.1136/bmjopen-2023-073242.
- 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.
Per C Valle, PhD principal investigator
University Hospital of North of Norway
Maria S Fjellstad, cand.med study chair
University Hospital of North of Norway
Hege M Hanssen, M.Sc study chair
University Hospital of North Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal microbiota transplantation in people with Obesity, Morbid, run by University Hospital of North Norway at 1 site in Norway.
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 1 inclusion and 9 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 20 Jan 2023. 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 Norway. 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?
Results are not available in the source record.
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?
Change in individual weight loss (kg). (time frame: Change from baseline body weight at 12 months post FMT). 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 NCT03273855, which also lists 1 linked publication.
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 20 Jan 2023.