Gut Microbiota Transplantation in Systemic Sclerosis

NCT ID: NCT03444220

Last Updated: 2019-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-18
• Study Completion Date: 2018-10-15

Brief Summary

Systemic Sclerosis (SSc) is a progressive multi-organ disorder with high disease burden. Life expectancy in SSc is reduced by 25-40 years, mainly due to cardiopulmonary and gastro-intestinal (GI) disease involvement; and a very poor response to available treatment. Aiming to improve treatment for SSc, the ReSScue project will determine the therapeutic potential of standardized, cultivated gut microbiome transplantation (GMT), and assess the mechanisms by which this novel intervention strategy works. This approach is rationalized by studies indicating that skewed gut microbiomes could act as major, environmental risk factors in SSc; and thereby be rational targets for therapeutic manipulation. ReSScue is set up as a 4 months randomized double blind trial involving the University Hospital in Oslo. Trial participants will be recruited from the population-based, nationwide SSc cohort. Intervention will be by GMT or placebo. Primary end point is changes in SSc-related GI parameters , while secondary outcomes include safety, explorative clinical parameters, changes in oral, skin and gut microbiomes, and in immune cell phenotypes.

Detailed Description

This is a randomized, double blind clinical trial testing intervention by standardized GMT. The study cohort will include 10 SSc patients with GI symptoms. Evaluation of end points is at 16 weeks. The trial is set up with six study visits. Patient recruitment, eligibility screening and retrieval of informed consent will be performed at OUS before inclusion. At visit 1, and 6 patients will undergo clinical examination, PFTs, at all visits clinical examination and sampling of biological material.

Conditions

Scleroderma, Systemic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

ACHIM

Anaerobically Cultivated Human Intestinal Microbiota

Group Type: ACTIVE_COMPARATOR

Anaerobically Cultivated Human Intestinal Microbiota

Intervention Type: BIOLOGICAL

30ml ACHIM will be administrated at week 0 and 2 with 14 days apart

Placebo

Anaerobically Cultivated medium

Group Type: PLACEBO_COMPARATOR

Anaerobically Cultivated medium

Intervention Type: BIOLOGICAL

30ml medium will be administrated at week 0 and 2 with 14 days apart

Interventions

Anaerobically Cultivated Human Intestinal Microbiota

30ml ACHIM will be administrated at week 0 and 2 with 14 days apart

Intervention Type: BIOLOGICAL

Anaerobically Cultivated medium

30ml medium will be administrated at week 0 and 2 with 14 days apart

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Fulfillment of the 2013 SSc classification criteria
• Objective GI involvement and provide informed consent.

Exclusion Criteria

• Severe organ dysfunction (and risk of procedure related complications
• Recent exposure to antibiotics

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Anna-Maria Hoffmann-Vold

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anna-Maria Hoffmann-Vold, PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

Oslo University Hospital

Oslo, , Norway

Countries

Norway

References

Strahm N, Didriksen H, Fretheim H, Molberg O, Midtvedt O, Farstad IN, Midtvedt T, Lundin KEA, Aabakken L, Blyszczuk P, Distler O, Kania G, Hoffmann-Vold AM. Effects of faecal microbiota transplantation on the small intestinal mucosa in systemic sclerosis. Rheumatology (Oxford). 2023 Aug 1;62(8):2918-2929. doi: 10.1093/rheumatology/kead014.

Reference Type: DERIVED

PMID: 36688692 (View on PubMed)

Other Identifiers

2016/1529

Identifier Type: -

Identifier Source: org_study_id