Probiotics in Systemic Lupus Erythematosus

NCT05433857 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-11-19

No results posted yet for this study

Summary

Dysbiosis, or disruption of the gut microbiota, leads to the onset of autoimmunity. Increasing data suggest that the gut microbiota is changed in various murine lupus models as well as in human systemic lupus erythematosus SLE patients. Ingestion of lactobacilli, which have immunoregulatory properties, may be a viable strategy for controlling disease development and progression in patients with lupus, such as increasing the remission period and decreasing flare frequency.

Conditions

Interventions

DRUG

Lacteol forte capsules

probiotic Lacteol Forte® capsules (5 billion heat-killed Lactobacillus LB, corresponding to lactobacillus delbruekii and lactobacillus fermentum) Two capsules are To be taken once daily

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Rana Sayed, PhD · Faculty of Pharmacy, Ain Shams University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-10
Primary Completion
2023-12-30
Completion
2024-02-28

Countries

  • Egypt

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05433857 on ClinicalTrials.gov