Gut Microbiota Transplantation in Systemic Sclerosis (ReSScue)

University of Oslo (UIO)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Scleroderma, Systemic

Treatments: Biological: Anaerobically Cultivated medium; Biological: Anaerobically Cultivated Human Intestinal Microbiota

Study type: Interventional

Funder types: Other

Identifiers

NCT03444220

2016/1529

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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10 participants in 2 patient groups, including a placebo group

ACHIM

Active Comparator group

Description:

Anaerobically Cultivated Human Intestinal Microbiota

Treatment:

Biological: Anaerobically Cultivated Human Intestinal Microbiota

Placebo

Placebo Comparator group

Description:

Anaerobically Cultivated medium

Treatment:

Biological: Anaerobically Cultivated medium