Effect of 4 Weeks of Oral Probiotic Desulfovibrio Piger Supplementation on Immunological and Metabolic Parameters in Individuals With Longstanding Type 1 Diabetes

Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study ID
NCT07585994
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Probiotic dietary supplement — DIETARY_SUPPLEMENT
    Probiotic bacteria D. piger (10\^9 colony forming units (CFU) in 10ml PBS containing 10% glycerol and 10% maltodextrin)
  • Placebo — DIETARY_SUPPLEMENT
    Placebo (10ml PBS containing 10% glycerol and 10% maltodextrin)

Study Details

The goal is to establish the effect of oral probiotic Desulfovibrio piger (D. piger) supplementation on immunological and metabolic parameters in individuals with longstanding type 1 diabetes with residual beta cell function. The investigators will perform a double-blind, randomized, placebo-controlled trial in 2x10 participants to measure effects of D. piger on parameters of systemic and intestinal inflammation and residual beta cell function.

Key Dates

First listed
May 14, 2026
Start date
May 31, 2026
Status verified
May 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Probiotic Desulfovibrio piger
    Probiotic bacteria D. piger (10\^9 colony forming units (CFU) in 10ml PBS containing 10% glycerol and 10% maltodextrin)
  • Placebo Comparator: Placebo
    placebo (10ml PBS containing 10% glycerol and 10% maltodextrin)

Primary Outcome Measure

Parameters of systemic and intestinal inflammation [ Time Frame: From start treatment to the end of treatment at 4 weeks and washout at 6 weeks. ]

Central Contacts

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