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Probiotic formulation for Sleep Disorder

Phase 2

Waitlist Available

Led By Charles Morin, Ph.D.

Research Sponsored by Lallemand Health Solutions

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

Study Summary

This trial is testing whether a probiotic can help improve sleep patterns.

Eligible Conditions

Sleep Patterns
Sleep Disorder

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Symptoms of insomnia

Secondary outcome measures

Change on Quality of life

Levels of sleep-related hormones

Mood

+9 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Experimental groupExperimental Treatment1 Intervention

Participants in this group will be randomized to receive probiotic formulation for the following 12 weeks.

Group II: Control groupPlacebo Group1 Intervention

Participants in this group will be randomized to receive placebo for the following 12 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Probiotic formulation

2014

Completed Phase 2

~340

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Lallemand Health SolutionsLead Sponsor

39 Previous Clinical Trials

3,649 Total Patients Enrolled

Charles Morin, Ph.D.Principal InvestigatorCentre de recherche CERVO

1 Previous Clinical Trials

132 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What safety measures have been established for Probiotic formulation intake?

"Our team at Power assessed the safety of Probiotic formulation to be a 2, as this is Phase 2 trial and there has been some evidence demonstrating its security but no proof of efficacy."

Answered by AI

How many participants are currently trialing this research endeavor?

"Affirmative. According to clinicaltrials.gov, this clinical trial is presently enrolling participants and was first established on October 12th 2021. Last updated on September 15th 2022, the research project is looking for 70 subjects from a single medical facility."

Answered by AI

Are elderly people being sought for inclusion in this exploratory research?

"According to the guidelines, people aged 18-65 are eligible for this medical trial. For those younger than 18 or older than 65, 32 and 96 trials respectively have been made available."

Answered by AI

To whom is enrollment in this research available?

"This clinical trial is currently accepting 70 individuals with dyssomnias aged between 18 and 65, who are willing to forgo probiotic supplements during the study. Furthermore, participants must have a score of 8 or higher on the ISI measure, 0.8 or higher on the ERI questionnaire and a body mass index (BMI) no greater than 30; otherwise they need to be in general good health."

Answered by AI

Is there room for additional participants in this research?

"Affirmative. According to information hosted on clinicaltrials.gov, this medical experiment, which was initially posted on October 12th 2021, is presently recruiting participants. Approximately 70 patients need to be recruited from a single centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Probiotics on Sleep Among Adults Study

2021. "Probiotics on Sleep Among Adults Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04767997.