Effect of B.Lactis Consumption on Gastro-Intestinal (GI) Symptoms in Healthy Women Reporting Minor GI Symptoms

NCT05416151 | Completed

• 1 other identifier: NU390
• Study Type: interventional
• Target: 486
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the effect of a 28-day B.lactis consumption twice daily on Gastro-Intestinal (GI) symptoms in healthy women reporting minor GI symptoms.

Conditions

Gastro-intestinal Symptoms in Healthy Subjects

Keywords

Gastro intestinal symptoms; Healthy women; Freeze-dried probiotic product; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Comparison between groups of scores of Digestive Symptoms Frequency Questionnaire (DSFQ) during 28 days of investigational product consumption (the higher the score, the more severe are the symptoms, min:0, no symptom, max:16).

  From Baseline to Visit 4 (28 days).

Secondary Outcomes (4)

• Comparison between groups of scores of Digestive Symptoms Frequency Questionnaire (DSFQ) during 28 days of investigational product consumption (the higher the score, the more severe are the symptoms, min:0, no symptom, max:16).

  From Baseline to each weekly evaluation visits (Week1 to Week 4) (4 weeks from baseline).

• Comparison between groups of scores of Intestinal Gas Questionnaire (IGQ) during 28 days of investigational product consumption (the higher the score, the more severe are the symptoms, min:0).

  From Week0 (V2) to each weekly evaluation visits (Week1 to Week4).

• Comparison between groups of scores of Profile of Mood States questionnaire Short Form (POMS-SF) during 28 days of investigational product consumption (a scoring guide needs to be follow to interpreted).

  From Week0 (V2) to Week2 (V3) and Week4 (V4).

• Comparison between and within groups of total and living bacteria cells counts of B.lactis (method PMA-PCR) during 28 days of investigational product consumption and after 1 week following product consumption cessation.

  Between Week0 (V2), Week2 (V3), Week4 (V4) and Week5 (V5).

Other Outcomes (12)

• Comparison between and within groups of Food Frequency Questionnaire (FFQ) during 28 days of investigational product consumption (an algorithm will be used to assess quantity and quality of nutriment intake, developed by MS Nutrition company).

  Between Week0 (V2) and Week4 (V4).

• Comparison between groups of scores of Digestive Symptoms Frequency Questionnaire (DSFQ) during 28 days of investigational product consumption (the higher the score, the more severe are the symptoms, min:0, no symptom, max:16).

  From Week0 (V2) to each weekly evaluation visits (Week1 to Week4).

• Comparison between groups of scores of Intestinal Gas Questionnaire (IGQ) during 28 days of investigational product consumption (the higher the score, the more severe are the symptoms, min:0).

  From Week0 (V2) to each weekly evaluation visits (Week1 to Week4).

Study Arms (2)

Arm 1, Test: freeze-dried B. lactis

OTHER

Other: Freeze-dried biotic

Arm 2, Control: freeze-dried maltodextrin

OTHER

Other: Maltodextrin

Interventions

Freeze-dried biotic OTHER

2 sticks of 3g consumed daily for 28 days

Arm 1, Test: freeze-dried B. lactis

Maltodextrin OTHER

2 sticks of 3g consumed daily for 28 days

Arm 2, Control: freeze-dried maltodextrin

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Gastro-intestinal symptoms are mostly reported in women subjects than in men.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Informed Consent SI01: Free-living Participant who fully understands and agree to the objectives of the study, who gave signed and dated informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
• Weight SI03: Subject with body mass index (BMI) between 18.0 and 30.0 kg/m2 (bounds included).
• Type of Participant and Disease Characteristics SI04: Subject with minor digestive symptoms as defined by composite score between 12 and 16 (bounds included) or at least one digestive symptom with a score ≥4 according to the screening questionnaire of frequency of digestive symptoms (DSFQ (R)).
• SI05: Subject with mean stool frequency between 3 and 21 bowel movements per week during the past month (bounds included) according to the screening questionnaire (DSFQ (R)).
• Sex SI06: Women of childbearing potential must be using a medically approved method of contraception (Oral birth control pills, Intra-uterine device (IUD) or Double barrier methods (such as condoms and spermicide)) OR women must be postmenopausal for at least 12 months prior to study entry OR women surgically sterile (i.e. hysterectomy, bilateral oophorectomy or bilateral tubal ligation).
• Other SI07: Subject willing to strictly follow dietary instructions (unauthorized products) for the entire duration of the study.
• SI08: Subject must have access to adequate space to store the investigational products (storage at 4°C) and the stools samples (storage in freezer) according to the labels' storage recommendations.
• SI09: Subject able to communicate well with the investigator and to comply with the requirements for the entire study.
• SI10: Subject covered by health insurance or covered by a similar system. SI11: Subject agrees to be registered in the National biomedical research file for volunteers.
• SI12: Subject willing to complete ePRO through a smartphone compatible with playstore or apple store and having access to internet.

You may not qualify if:

• \- Medical Conditions and History SE01: Pregnant women based on pregnancy test or planning to become pregnant during the study's participation or lactating women.
• SE02: Subject with disorder of gut brain interactions according to ROME IV criteria (Functional Bowel Disorders/FBD module, Functional Dyspepsia/FD module).
• SE03: Subject with gastrointestinal disorders other than minor digestive symptoms as defined in SI04 according to investigator's medical assessment.
• SE04: Subject who have consulted for gastrointestinal disorders within 6 months prior to the screening visit (V1).
• SE05: Subject who had any dental surgery within the last 4 weeks, or who plans to have one during the study, excluding care of tooth decay.
• SE06: Subject with any antecedents of digestive surgery (except for appendectomy and cholecystectomy performed more than 2 years ago).
• SE07: Subject with previous history of drug or alcohol abuse 6 months prior to screening.
• SE08: Subject with severe disease as assessed by the investigator (e.g inflammatory bowel disease, benign or malign tumor of intestine or colon cancer, severe heart disease, kidney disease, neurological disease or psychiatric disease, immunodeficiency disorder).
• \- Prior/Concomitant Therapy SE09: Subject with any intake of antibiotics or intestinal antiseptics in the previous 2 months (within 60 days) prior to the screening visit (V1).
• SE10: Subject with any intake of drugs that might modify gastrointestinal function (e.g regular use of laxatives, anti-diarrhea, prokinetics, proton pump inhibitors (PPIs)) in the previous 2 weeks (within 14 days) prior to the screening visit (V1).
• SE11: Subject with any intake of over-the-counter yeasts or probiotics supplements (such as pills, tablets, sachets or sticks) in the previous 2 weeks (within 14 days) prior to the screening visit (V1).
• SE12: Subject who underwent a general anesthesia in the preceding 4 weeks. SE13: Subject with known allergy to study products component (maltodextrin for example).
• SE14: Subject with any current use of any medication with potential central nervous system effects as judged by the investigator (including but not limited to opiate pain medication).
• Diet SE16: Change of dietary habits within the 4 weeks preceding the V1 (for instance start of a diet rich in fiber) or planned change (for example to start a new diet during the study's participation).
• SE18: Subject under guardianship or curatorship. SE19: Subject expected to be living in the same home as a subject currently participating to the present study (or willing to) and to concomitantly receive some study products.

Sponsors & Collaborators

• Danone Global Research & Innovation Center: lead
• Euraxi Pharma: collaborator

Study Sites (1)

CEN Experimental

Dijon, 21000, France

Location

MeSH Terms

Interventions

maltodextrin

Study Officials

• Rim HASSOUNA, PhD

  Danone Research, Palaiseau, France

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study Test and Control products have similar appearance including packaging and texture, smell, and taste, in order to preserve the double-blind methodology. The blinding of study products will be performed by assigning a study product number corresponding to the randomization list. Then blinded study product packages will be carried to the investigational site for assignment to the subjects. Product allocation will be performed by randomized method (IWRS validated system) as it is a Randomized Controlled Trial. The participants are thus assigned to intervention groups randomly.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A proof-of-efficacy, randomized, controlled, double-blind, monocentric, parallel arms design

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: June 13, 2022
• Study Start: May 24, 2022
• Primary Completion: December 15, 2023
• Study Completion: April 18, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)