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RecruitingNCT06936137Updated Apr 20, 2025

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

A Phase 3 interventional study of lactobacillus LS in Antipsychotic Induced Weight Gain, sponsored by Ain Shams University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-04-20.

Sponsored by Ain Shams University · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as recruiting.
Phase
Phase 3
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

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.
02

Conditions studied

  • Antipsychotic Induced Weight Gain

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03

In context

Weight Gain

317 studies on the registry are indexed under Weight Gain; 48 are open to participants now.

This study's planned enrollment of 180 is above the median of 83 across 251 interventional studies indexed under Weight Gain.

Browse Weight Gain studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.

Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

    -

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
180 participants (estimated)

Study arms

  • Experimental
    Probiotic supplementation (Lacteol fort 10 billion) which contains culture medium and lactobacillus

    Drug: lactobacillus LS

  • No intervention
    Participants will be advised to be adherent to their standard treatment and followed up regularly.

Interventions

  • Druglactobacillus LS

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

06

What researchers measure

Primary outcomes

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

    Time frame: 12 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06936137
Responsible party
Sponsor
First posted
Apr 20, 2025
Start date
Apr 20, 2025 (estimated)
Primary completion
Jun 20, 2026 (estimated)
Completion
Dec 20, 2026 (estimated)
Last update
Apr 20, 2025

Study contacts

Rehab Abdelmaksoud
Contact
rehab.abdelmaksoud@med.asu.edu.eg
02 01158336110

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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