Effect of 4 Weeks of Oral Probiotic Desulfovibrio Piger Supplementation on Immunological and Metabolic Parameters in Individuals With Longstanding Type 1 Diabetes (PROSPER)
10. mai 2026 oppdatert av: Max Nieuwdorp, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The investigators perform a double-blind, randomized, placebo-controlled trial with two arms (10 participants per arm, total of 20 participants) in adults with longstanding type 1 diabetes with residual beta cell function. The study duration is 6 weeks, with 4 weeks of intervention in which participants will be given D. piger or placebo once daily and 2 weeks of washout period. The main study enpoints include the changes (versus baseline) in parameters of systemic/intestinal inflammation and beta cell function between the placebo and D.piger-treatment arms at the end of treatment (4 weeks). In addition, any long-lasting effects will be determined by assessing the changes in the above described markers after a 2 week washout period (6 weeks).
Secondary endpoints include glucose variability (continuous glucose monitoring, CGM), fecal microbiome composition (including strain engraftment of D. piger, plasma metabolites), immune cell phenotype and frequency and validated questionnaires (gastro-intestinal complaints) at these three timepoints (0,4,6 weeks).
Studietype
Intervensjonell
Registrering (Antatt)
20
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Max Nieuwdorp, Prof. Dr.
- Telefonnummer: +31 20-5669111
- E-post: m.nieuwdorp@amsterdamumc.nl
Studiesteder
-
-
-
Amsterdam, Nederland, 1105 AZ
- Rekruttering
- Amsterdam UMC
-
Ta kontakt med:
- Max Nieuwdorp, Prof. Dr.
- Telefonnummer: +31 20-5669111
- E-post: m.nieuwdorp@amsterdamumc.nl
-
Amsterdam, Nederland, 1066 EC
- Rekruttering
- Diabeter Centrum Amsterdam
-
Ta kontakt med:
- Max Nieuwdorp, Prof. Dr.
- Telefonnummer: +31 20-5669111
- E-post: m.nieuwdorp@amsterdamumc.nl
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Probiotic Desulfovibrio piger
Probiotic bacteria D. piger (10^9 colony forming units (CFU) in 10ml PBS containing 10% glycerol and 10% maltodextrin)
|
Probiotic bacteria D. piger (10^9 colony forming units (CFU) in 10ml PBS containing 10% glycerol and 10% maltodextrin)
|
|
Placebo komparator: Placebo
placebo (10ml PBS containing 10% glycerol and 10% maltodextrin)
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Placebo (10ml PBS containing 10% glycerol and 10% maltodextrin)
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Parameters of systemic and intestinal inflammation
Tidsramme: From start treatment to the end of treatment at 4 weeks and washout at 6 weeks.
|
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
Tidsramme: From start treatment to the end of treatment at 4 weeks and washout at 6 weeks.
|
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.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Glucose variability
Tidsramme: From start treatment to the end of treatment at 4 weeks and washout at 6 weeks.
|
percentage time in euglycemic range, time above range, time below range and glucose variability measured by continuous glucose monitoring (CGM)
|
From start treatment to the end of treatment at 4 weeks and washout at 6 weeks.
|
|
Immune cell phenotypes and frequency
Tidsramme: From start treatment to the end of treatment at 4 weeks and washout at 6 weeks.
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Immunophenotyping by flow cytometry of PBMC (peripheral blood mononuclear cells) to determine frequency of T cell subsets with activation/exhaustion marker expression
|
From start treatment to the end of treatment at 4 weeks and washout at 6 weeks.
|
|
Fecal microbiome composition and strain engraftment
Tidsramme: From start treatment to the end of treatment at 4 weeks and washout at 6 weeks.
|
using 16s rRNA sequencing, primer-specific quantitative PCR for D. piger detection in feces and plasma metabolites
|
From start treatment to the end of treatment at 4 weeks and washout at 6 weeks.
|
|
Gastrointestinal Symptom Rating Scale (GSRS)
Tidsramme: From start treatment to the end of treatment at 4 weeks and washout at 6 weeks.
|
Questionnaire.
The minimum and maximum score are 15 and 105 points respectively, and a higher score in the scale reflects more gastro-intestinal complaints.
|
From start treatment to the end of treatment at 4 weeks and washout at 6 weeks.
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Max Nieuwdorp, Prof. Dr., Amsterdam UMC
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. mai 2026
Primær fullføring (Antatt)
1. mai 2028
Studiet fullført (Antatt)
1. mai 2028
Datoer for studieregistrering
Først innsendt
5. mai 2026
Først innsendt som oppfylte QC-kriteriene
10. mai 2026
Først lagt ut (Faktiske)
14. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
14. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2025.1139
Plan for individuelle deltakerdata (IPD)
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NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
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Nei
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