Probiotics on Sleep Among Adults Study

NCT04767997 | Completed Phase 2

• 1 other identifier: L-019
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine the impact of a probiotic formulation on subjective sleep patterns. It is hypothesized that participants given the probiotics will improve their sleep patterns compared to participants receiving placebo.

Conditions

Sleep Disturbance; Sleep Patterns

Outcome Measures

Primary Outcomes (1)

• Symptoms of insomnia

  Comparison of sleep quality assessed by the Insomnia Severity Index among probiotic versus placebo

  12 weeks

Secondary Outcomes (12)

• Symptoms of insomnia (progressive treatment)

  6 weeks

• Objective assessment of sleep: Sleep Latency

  12 weeks

• Objective assessment of sleep: Sleep Efficiency

  12 weeks

• Objective assessment of sleep: Wake after sleep onset (WASO)

  12 weeks

• Subjective sleep patterns

  12 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Dietary Supplement: Probiotic formulation

Control group

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Probiotic formulation DIETARY_SUPPLEMENT

Participants will be asked to take one capsule daily, containing 3 billion CFU of the probiotics.

Experimental group

Placebo DIETARY_SUPPLEMENT

Participants will be asked to take a placebo capsule daily.

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged between 18 and 65 years-old
• Scores 8 ≥ in the ISI
• Having a score higher to 0.8 in the ERI questionnaire
• Body mass index (BMI) below or equal to 30.
• Otherwise healthy
• Working (paid or unpaid) at the same position for at least the past 3 months and plans to have the same position for the duration of the study.
• Willing to discontinue consumption of probiotics supplements and probiotic fortified products throughout the study

You may not qualify if:

• Presence of unrelated sleep disorders (Obstructive Sleep Apnea and REM Sleep Behavior Disorder) as per questionnaires (STOP BANG and the RBD single question, respectively).
• Diagnosis of mental disorders (diagnosed by a health professional in the last year, including insomnia) or showing high psychosocial stress assessed by K10 (score equal or above 17).
• Diabetes (type I and II), blood/bleeding disorders, liver and/or kidney disorders, unstable cardiovascular diseases, neurological diseases (such as, but not limited to Alzheimer's disease, Parkinson's disease, epilepsy), gastrointestinal diseases (such as, but not limited to gastric ulcers, Crohn's disease, ulcerative colitis).
• Irregular bedtime schedule (schedule resulting in usual bedtime earlier than 8 PM or later than 2 AM or arising time earlier than 4 AM or later than 10 AM).
• Currently suffering from periodontitis.
• Pregnancy, planning to be pregnant or currently breastfeeding.
• Use of medication to improve sleep, such as Zopiclone, Doxepine, Trazodone, Melatonin, any H1-antagonist, antipsychotics.
• Milk and soy allergy.
• Lactose intolerance.

Sponsors & Collaborators

• Lallemand Health Solutions: lead

Study Sites (1)

Centre d'étude des troubles du sommeil, Centre de recherche CERVO/BRAIN

Québec, G1J 2G2, Canada

Location

MeSH Terms

Conditions

Parasomnias

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Charles Morin, Ph.D.

  Centre de recherche CERVO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2021
• First Posted: February 24, 2021
• Study Start: October 12, 2021
• Primary Completion: May 3, 2023
• Study Completion: May 3, 2023
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)