Evidence Based Probiotic Therapy of Proton Pump Inhibitor Induced Dysbiosis

NCT05836155 | Active Not Recruiting

• 1 other identifier: 35-175 ex 22/23
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

In this study the investigators aim to test whether an evidence based probiotic is able to revert proton pump inhibitor induced dysbiosis of the gut microbiome.

Conditions

Dysbiosis

Outcome Measures

Primary Outcomes (1)

• Changes in overall symptom score

  Gastrointestinal quality of life index (GIQLI)

  3 months

Secondary Outcomes (9)

• Other dimension of gastrointestinal quality of life

  3 months

• Composition of the faecal metabolome

  3 months

• Zonulin

  3 months

• Calprotectin

  3 months

• Diaminooxidase

  3 months

Study Arms (1)

Intervention

EXPERIMENTAL

The study product contains Bifidobacterium animalis W53, Lactobacillus acidophilus W55, Lactobacillus casei W56, Lactobacillus plantarum W1, Lactobacillus plantarum W21, Lactobacillus rhamnosus W71, and Pediococcus acidilactici W143.

Dietary Supplement: Intervention

Interventions

Intervention DIETARY_SUPPLEMENT

multispecies probiotic

Intervention

Eligibility Criteria

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

You may qualify if:

• Age \>18;
• Signed Informed Consent;
• PPI intake for at least 3 months;

You may not qualify if:

• Diagnosed with a gastrointestinal infection within 4 weeks prior to screening; Severe gastrointestinal disorders (e.g. inflammatory bowel diseases)
• Received any of the following products/medication prior to screening: systemic antibiotics, prokinetics, prebiotic supplements, probiotic supplements within 4 weeks prior to screening;
• Concomitant diseases or other circumstances that suggest that the patients are not eligible for participation in the study

Sponsors & Collaborators

• Medical University of Graz: lead
• CBmed Ges.m.b.H.: collaborator

Study Sites (1)

Medical University Graz

Graz, Austria

Location

MeSH Terms

Conditions

Dysbiosis

Interventions

Methods

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. PD Dr

Model Details: unblinded longitudinal study will be performed

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: May 1, 2023
• Study Start: July 10, 2023
• Primary Completion: January 19, 2024
• Study Completion: July 1, 2025
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Microbiome data will be shared in a public repository when the paper will be submitted, other data will depend on results and IPR discussions between partners

Locations

AU (1)