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

NCT07585994 | Recruiting DMC

• 1 other identifier: 2025.1139
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Type 1 Diabetes Mellitus

Keywords

type 1 diabetes mellitus; gut microbiome; probiotics; immunological parameters; residual beta cell function

Outcome Measures

Primary Outcomes (2)

• Parameters of systemic and intestinal inflammation

  systemic inflammation determined by measuring plasma CRP, and proinflammatory cytokines (IFNgamma, IFN alpha, TNFalpha) intestinal inflammation assessed by LB, iFABP, zonulin in plasma

  From start treatment to the end of treatment at 4 weeks and washout at 6 weeks.

• Residual beta cell function

  Assessed by C peptide AUC during mixed meal tolerance test and/or post meal urine C-peptide/creatinine ratio levels.

  From start treatment to the end of treatment at 4 weeks and washout at 6 weeks.

Secondary Outcomes (4)

• Glucose variability

  From start treatment to the end of treatment at 4 weeks and washout at 6 weeks.

• Immune cell phenotypes and frequency

  From start treatment to the end of treatment at 4 weeks and washout at 6 weeks.

• Fecal microbiome composition and strain engraftment

  From start treatment to the end of treatment at 4 weeks and washout at 6 weeks.

• Gastrointestinal Symptom Rating Scale (GSRS)

  From start treatment to the end of treatment at 4 weeks and washout at 6 weeks.

Study Arms (2)

Probiotic Desulfovibrio piger

EXPERIMENTAL

Probiotic bacteria D. piger (10\^9 colony forming units (CFU) in 10ml PBS containing 10% glycerol and 10% maltodextrin)

Dietary Supplement: Probiotic dietary supplement

Placebo

PLACEBO COMPARATOR

placebo (10ml PBS containing 10% glycerol and 10% maltodextrin)

Dietary Supplement: Placebo

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)

Probiotic Desulfovibrio piger

Placebo DIETARY_SUPPLEMENT

Placebo (10ml PBS containing 10% glycerol and 10% maltodextrin)

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females, age \>18 years
• A diagnosis of type 1 diabetes, with duration of more than 5 years, with minimally one of antiGAD65, IA2, ZnT8 autoantibodies present assessed at diagnosis or routine visits at Diabeter Centrum.
• Evidence of remaining residual beta cell function with detectable UCPCR (more than 0.01 nmol/mmol C-peptide/creatinine ratio) and or fasting plasma C-peptide more than 0.2 mmol/L.
• BMI 18-30 kg/m2

You may not qualify if:

• Use of antibiotics or proton-pump inhibitors within the last three months before screening or during study period
• Use of other probiotic supplementation within the last month before screening or during study period
• A history of cholecystectomy
• Overt untreated gastrointestinal disease, inflammatory bowel disease or abnormal bowel habits
• Absence of a large bowel (ie colostomy)
• Evidence for comprised immunity (HIV infection, chemotherapy, other autoimmune diseases, systemic anti-inflammatory therapy)
• History of cardiovascular disaeses (CVD) events
• Hepatic enzymes\>2.5 higher than the upper limit of normal range, determined during MARVEL visits/routine visits
• Kidney failure (eGFR \<15ml.min/1.73m2), dialysis, kidney transplantation,
• Inability or unwillingness to donate feces or urine.
• Smoking or illicit drug use (e.g. MDMA/amphetamine/cocaine/heroin/GHB) in the past three months or use during the study period.
• Alcohol abuse (equal or above 21 units per week)
• Inability or unwillingness to provide informed consent.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (2)

Diabeter Centrum Amsterdam

Amsterdam, 1066 EC, Netherlands

RECRUITING

Amsterdam UMC

Amsterdam, 1105 AZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Max Nieuwdorp, Prof. Dr.

  Amsterdam UMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Max Nieuwdorp, Prof. Dr.

CONTACT

+31 20-5669111; m.nieuwdorp@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The unblinded researcher will provide the study intervention to the blinded investigator in a coded fashion. Both the investigator and the participant are blinded. In case of emergency, an unblinding protocol is activated.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator (prof dr)

Model Details: 2x10 participants will be randomly allocated to probiotic D. piger or placebo once daily for 4 weeks.

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 14, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)