NCT03273855

Brief 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. We will also collect data that possibly could give a better understanding of mechanisms of this correlation.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 6, 2017

Completed
1.7 years until next milestone

Study Start

First participant enrolled

May 13, 2019

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

January 20, 2023

Status Verified

January 1, 2023

Enrollment Period

4 years

First QC Date

August 31, 2017

Last Update Submit

January 18, 2023

Conditions

Obesity, Morbid

Outcome Measures

Primary Outcomes (1)

  • 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.

    Change from baseline body weight at 12 months post FMT

Secondary Outcomes (20)

  • Change in individual weight loss (kg)

    Change from baseline body weight at 3, 6 and 12 months after FMT

  • Change in waist circumference (cm)

    Change from baseline waist circumferense at 3, 6 and 12 months after FMT

  • Changes in HbA1c (mmol/mol)

    Change from baseline HbA1c at 3, 6 and 12 months after FMT

  • Changes in fasting glucose (mmol/L)

    Change from baseline fasting glucose at 3, 6 and 12 months after FMT

  • Changes in insuline (pmol/L)

    Change from baseline insuline at 3, 6 and 12 months after FMT

  • +15 more secondary outcomes

Other Outcomes (3)

  • Engraftment of donor microbiota at 1, 3, 6 and 12 months.

    Inclusion, 2, 3, 6 and 12 months after FMT

  • Eating behaviour

    Change from baseline binge eating questionnaore score 12 months after FMT

  • Questionnaire about the impact of covid-19 on life style changes and eating habits

    Once during the follow up period in the study

Study Arms (2)

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.

Other: Fecal microbiota transplantation

Placebo

PLACEBO COMPARATOR

Placebo. Patient will recieve an autologous fecal microbiota transplantation.

Other: Placebo: fecal microbiota transplantation

Interventions

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.

Intervention
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.

Placebo

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI \> 40 or BMI \> 35 kg/m2 combined with comorbidity related to obesity.

You may not qualify if:

  • 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.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of North Norway

Harstad, Troms, 9406, Norway

Location

Related Publications (1)

  • 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.

    PMID: 38151280DERIVED

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Officials

  • Per C Valle, PhD

    University Hospital of North of Norway

    PRINCIPAL INVESTIGATOR

  • Maria S Fjellstad, cand.med

    University Hospital of North of Norway

    STUDY CHAIR

  • Hege M Hanssen, M.Sc

    University Hospital of North Norway

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double-blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2017

First Posted

September 6, 2017

Study Start

May 13, 2019

Primary Completion

May 1, 2023

Study Completion

May 1, 2023

Last Updated

January 20, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)