NCT03391817

Brief Summary

40 patients meeting the criteria for obesity surgery are enrolled. Fecal microbiota transplantation (FMT) will be administered in gastroscopy 6 months before obesity surgery. 20 of the patients will receive a fecal transplant of a thin donor and 20 will receive placebo - a transplant made of their on feces. Changes in weight, laboratory values, general well being and stool microbiota will be measured up to one year after the surgery; one and a half years after FMT. The hypothesis is that FMT and the change in gut microbiota will help to reduce and maintain lower weight.

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
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

December 30, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 5, 2018

Completed
14 days until next milestone

Study Start

First participant enrolled

January 19, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
Last Updated

August 15, 2019

Status Verified

August 1, 2019

Enrollment Period

3.1 years

First QC Date

December 30, 2017

Last Update Submit

August 14, 2019

Conditions

Obesity, Morbid

Outcome Measures

Primary Outcomes (1)

  • Reduction of weight

    1,5 years

Study Arms (2)

Intervention arm

ACTIVE COMPARATOR

Fecal transplant from a thin donor

Other: Fecal microbiota transplantation

Placebo arm

PLACEBO COMPARATOR

Fecal transplant made from patients own feces

Other: Fecal microbiota transplantation

Interventions

Fecal microbiota transplantationOTHER

Fecal microbiota transplantation administered in gastroscopy

Intervention armPlacebo arm

Eligibility Criteria

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

You may qualify if:

  • Candidates for the bariatric surgery
  • BMI ≥ 40 or BMI ≥35 and at least two obesity-related co-morbidities such as type II diabetes (T2DM), hypertension, sleep apnea and other respiratory disorders, non-alcoholic fatty liver disease, osteoarthritis, lipid abnormalities, gastrointestinal disorders, or heart disease.
  • Availability of consecutive fecal samples during one year
  • Compliance to attend gastroscopy and FMT
  • years

You may not qualify if:

  • Unable to provide informed consent
  • Pregnancy
  • Type I Diabetes Mellitus
  • Severe renal insufficiency, GFR\<30%
  • Chronic or recurrent bacterial infection needing antimicrobial treatment
  • Large hiatal hernia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Helsinki University Hospital

Helsinki, Finland

RECRUITING

Päijät-Häme Central Hospital

Lahti, Finland

RECRUITING

Related Publications (1)

  • Lahtinen P, Juuti A, Luostarinen M, Niskanen L, Liukkonen T, Tillonen J, Kossi J, Ilvesmaki V, Viljakka M, Satokari R, Arkkila P. Effectiveness of Fecal Microbiota Transplantation for Weight Loss in Patients With Obesity Undergoing Bariatric Surgery: A Randomized Clinical Trial. JAMA Netw Open. 2022 Dec 1;5(12):e2247226. doi: 10.1001/jamanetworkopen.2022.47226.

    PMID: 36525272DERIVED

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

  • Perttu Arkkila, PhD MD

    Helsinki University Central Hospital

    STUDY DIRECTOR

Central Study Contacts

Perttu Lahtinen, MD

CONTACT

+358447195256perttu.lahtinen@phhyky.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2017

First Posted

January 5, 2018

Study Start

January 19, 2018

Primary Completion

February 28, 2021

Study Completion

February 28, 2021

Last Updated

August 15, 2019

Record last verified: 2019-08

Locations

FI(2)