Antipsychotic Induced Weight GainPhase 3NCT06936137
: 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 study testing lactobacillus LS in people with Antipsychotic Induced Weight Gain, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Antipsychotic Induced Weight Gain
- What is being tested?
- lactobacillus LS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Apr 2025to 20 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
AinShams university hospitals
Cairo, Abbassia, 00202
About this study
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:
- To determine the effect of probiotic supplementation on the psychological state of patients.
- Conditions
- Antipsychotic Induced Weight Gain
- Being tested
- lactobacillus LS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lactobacillus LSDrug
Probiotic supplementation (Lacteol fort 10 billion) which contains culture medium and lactobacillus LS as active ingredients
| Study group | Role | What they receive |
|---|---|---|
| Probiotic supplementation (Lacteol fort 10 billion) which contains culture medium and lactobacillus | Experimental | Not described Receives: Drug: lactobacillus LS |
| Participants will be advised to be adherent to their standard treatment and followed up regularly. | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effectiveness of probiotics to decrease the weight gained as a result of antipsychotic medications.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start20 Apr 2025 (estimated)
- Primary completion20 Jun 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antipsychotic Induced Weight GainStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06936137
- Sponsor's protocol ID
- MD343/2024
- Status last verified
- Apr 2025
- First submitted
- 13 Apr 2025
- Last updated
- 20 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- : EFFECT OF PROBIOTIC SUPPLEMENTATION ON ATYPICAL ANTIPSYCHOTIC INDUCED WEIGHT GAIN IN PATIENTS ATTENDING PSYCHIATRIC CLINICS AT AINSHAMS UNIVERSITY HOSPITALS (A RANDOMIZED CONTROLLED TRIAL)
- ClinicalTrials.gov ID
- NCT06936137
- Acronym / sponsor ID
- MD343/2024
- Conditions
- Antipsychotic Induced Weight Gain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Apr 2025 (estimated)
- Primary completion
- 20 Jun 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 20 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To determine the effect of probiotic supplementation on the psychological state of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic supplementation (Lacteol fort 10 billion) which contains culture medium and lactobacillus | Experimental | Drug: lactobacillus LS |
| Participants will be advised to be adherent to their standard treatment and followed up regularly. | No intervention | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lactobacillus LSProbiotic supplementation (Lacteol fort 10 billion) which contains culture medium and lactobacillus LS as active ingredients | Drug | Probiotic supplementation (Lacteol fort 10 billion) which contains culture medium and lactobacillus |
Primary outcome
To determine the effectiveness of probiotics to decrease the weight gained as a result of antipsychotic medications.
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing lactobacillus LS in people with Antipsychotic Induced Weight Gain, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rehab Abdelmaksoud (02 01158336110, rehab.abdelmaksoud@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the effectiveness of probiotics to decrease the weight gained as a result of antipsychotic medications. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2025.