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Standardized Microbiota Transplant Therapy in Crohn's Disease

ConditionCrohn Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-89
SponsorUniversity of Minnesota

About this trial

Crohn's disease (CD) develops because of a disruption of homeostasis between the gut microbiota and the host immune system resulting in excessive inflammation in the intestinal tract. Current drug therapies for CD are directed at the immune system. The emergence of fecal microbiota transplantation (FMT) for the treatment of recurrent C. difficile infections (rCDI) has opened a frontier of restorative therapies targeting the gut microbiome. This study aims to assess if two forms of encapsulated FMT material (MTP101C and MTP101S) can effectively engraft in the ileum and colon of individuals with CD. This study will also assess how the impact of CD phenotype impacts engraftment. Finally this study will explore symptom and endoscopic changes before and after these two therapies.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Able and willing to provide informed consent.

18-89 years of age.

English speaking.

Diagnosis of CD based on typical clinical and histologic features.

Disqualifiers

Extensive bowel resection: i.e., subtotal colectomy or substantial removal of small bowel where short bowel syndrome could be a concern.

Documented gastroparesis

History of pylorus non-preserving gastric surgery, e.g., Roux-en-Y gastric bypass.

Cannot be traversed by the colonoscope,

Trial design

Design model

Parallel

Treatments tested in this trial

  • MTP-101C

    Biological/Vaccine

    MTP-101C composed of double-encapsulated freeze-dried healthy donor microbiota. The fecal microbiota is frozen in the presence of a lyoprotectant (trehalose), freeze-dried, and double encapsulated into hypromellose capsules (Lonza, Morristown, NJ). Each capsule contains ≥ 1 x 10 11 and ≤ 2.0 x 10 11 bacterial cells.

  • MTP-101S

    Biological/Vaccine

    MTP-101S contains identical healthy donor microbiota double encapsulated in VCaps Plus (Lonza). These capsules are also composed of hypromellose but disintegrate in the proximal small bowel. Each capsule contains ≥ 1 x 10 11 and ≤ 2.0 x 10 11 bacterial cells.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: CD patients randomized to MTP-101CExperimental treatment 1 intervention
Group B: CD patients randomized to MTP-101SExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

donor microbial engraftment

measured in intestinal ileal biopsies

Time frame
2months

Secondary outcomes

1

Changes in ileal microbial composition

biopsy samples, between baseline and 2 months

Time frame
2 months
2

Colonic engraftment of donor microbiota

colonic biopsies

Time frame
2 months
3

Changes in colonic microbial composition

Time frame
2 months
4

Engraftment

measured by fecal samples over the study period.

Time frame
2 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Minnesota

Lead sponsor

Source ClinicalTrials.gov
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