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NCT Number: NCT06936137

: EFFECT OF PROBIOTIC SUPPLEMENTATION ON ATYPICAL ANTIPSYCHOTIC INDUCED WEIGHT GAIN IN PATIENTS ATTENDING PSYCHIATRIC CLINICS AT AINSHAMS UNIVERSITY HOSPITALS (A RANDOMIZED CONTROLLED TRIAL)

the goal of the study is to improve the quality of life of patients on antipsychotic medications and increase the rate of compliance to treatment.

Primary objective:

1.To determine the effectiveness of probiotics to decrease the weight gained as a result of antipsychotic medications.

Secondary objective:

1. To determine the effect of probiotic supplementation on the psychological state of patients.

Recruiting

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Key information

Conditions

Antipsychotic Induced Weight Gain

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

AinShams university hospitals

Cairo, Abbassia, 00202, Egypt

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult schizophrenia patients (18-45 years) on second generation antipsychotics Stable patients with a total positive and negative syndrome scale (PANSS) score of ≤60.

With more than 10% weight gain after taking atypical antipsychotics for at least 3 months with treatment duration not more than two years.

Exclusion criteria

  • Taking probiotics, fiber supplements, antibiotics and laxatives in the last 6 weeks.
  • Comorbid gastrointestinal diseases, including active peptic ulcer, uncontrolled and recurrent diarrhea, gastrointestinal bleeding, and digestive system neoplastic diseases.

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Treatment and study plan

lactobacillus LS

Drug

Probiotic supplementation (Lacteol fort 10 billion) which contains culture medium and lactobacillus LS as active ingredients

Primary outcomes

  1. To determine the effectiveness of probiotics to decrease the weight gained as a result of antipsychotic medications.

    Time frame: 12 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Rehab Abdelmaksoud

CONTACT

[email protected]

02 01158336110

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 20, 2025
Registry last updated
Apr 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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