Gastro-intestinal Symptoms in Healthy SubjectsNCT05416151
Effect of B.Lactis Consumption on Gastro-Intestinal (GI) Symptoms in Healthy Women Reporting Minor GI Symptoms
A study testing Freeze-dried biotic and Maltodextrin in people with Gastro-intestinal Symptoms in Healthy Subjects, run by Danone Global Research & Innovation Center at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gastro-intestinal Symptoms in Healthy Subjects
- What is being tested?
- Freeze-dried biotic and Maltodextrin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 486 participants
- Where
- 1 siteFrance
- Study dates
- 24 May 2022to 18 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- Age SI02: Women between the ages of 18 and 60 years (bounds included), at the time of signing the informed consent at the inclusion visit.
- 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).
Show all 11Show fewer
- 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.
Who cannot join
- 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).
Show all 20Show fewer
- 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).
- Prior/Concurrent Clinical Study Experience SE15: Subject who has planned to participate in another investigational study during the period of this study OR subject involved in any other clinical study within the preceding month except for non-investigational procedures (e.g: CT scan, endoscopy capsule) OR subject in the exclusion period after participation in another clinical study.
- 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).
- Other Exclusions SE17: Vulnerable subjects defined as individuals whose willingness to volunteer in the clinical study may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate (examples are members of a group with a hierarchical structure linked to the Investigator or to the Sponsor, such as medical, pharmacy, dental and nursing students, subordinate hospital and laboratory personnel, employees of the Investigator or of the Sponsor, members of the armed forces, and persons kept in detention).
- 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.
- SE20: Subject planning to start or quit smoking during the study's participation.
- SE21: Subject in a situation, which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the subject.
- SE22: Subject not able to understand and/or to answer to the questions. SE23: Athletes as defined as routinely performing strenuous daily exercise for more than 1.5 hours at a time.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of a 28-day B.Lactis Consumption Twice Daily on Gastro-Intestinal (GI) Symptoms in Healthy Women Reporting Minor GI Symptoms. A Proof of Efficacy, Randomized, Controlled, Double-blind, Parallel Arms, Adaptive Design.
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.
- Being tested
- Freeze-dried biotic, Maltodextrin
- Keywords
- Gastro intestinal symptoms, Healthy women, Freeze-dried probiotic product, Randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freeze-dried bioticOther
2 sticks of 3g consumed daily for 28 days
MaltodextrinOther
2 sticks of 3g consumed daily for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Arm 1, Test: freeze-dried B. lactis | Other | Not described Receives: Other: Freeze-dried biotic |
| Arm 2, Control: freeze-dried maltodextrin | Other | Not described Receives: Other: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Between Week0 (V2), Week2 (V3), Week4 (V4) and Week5 (V5).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start24 May 2022
- Primary completion15 Dec 2023
- Study completion18 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro-intestinal Symptoms in Healthy SubjectsStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A proof-of-efficacy, randomized, controlled, double-blind, monocentric, parallel arms design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 486 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danone Global Research & Innovation Center
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Euraxi Pharma
- Responsible party
- Sponsor
- Investigators
- Rim HASSOUNA, PhD, Study chair, Danone Research, Palaiseau, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05416151
- Sponsor's protocol ID
- NU390
- Status last verified
- Aug 2024
- First submitted
- 12 May 2022
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of a 28-day B.Lactis Consumption Twice Daily on Gastro-Intestinal (GI) Symptoms in Healthy Women Reporting Minor GI Symptoms. A Proof of Efficacy, Randomized, Controlled, Double-blind, Parallel Arms, Adaptive Design.
- ClinicalTrials.gov ID
- NCT05416151
- Acronym / sponsor ID
- NU390
- Keywords
- Gastro intestinal symptoms, Healthy women, Freeze-dried probiotic product, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 486 participants (actual)
- Lead sponsor
- Danone Global Research & Innovation CenterIndustry (pharma, biotech, devices)
- Collaborators
- Euraxi Pharma
- Study start
- 24 May 2022 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 18 Apr 2024 (actual)
- First posted
- 13 Jun 2022 (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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A proof-of-efficacy, randomized, controlled, double-blind, monocentric, parallel arms design
| Arm | Type | Receives |
|---|---|---|
| Arm 1, Test: freeze-dried B. lactis | Other | Other: Freeze-dried biotic |
| Arm 2, Control: freeze-dried maltodextrin | Other | Other: Maltodextrin |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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.
- Age SI02: Women between the ages of 18 and 60 years (bounds included), at the time of signing the informed consent at the inclusion visit.
- 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)).
Key exclusion criteria (20 listed)
- 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.
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 |
|---|---|---|
| Freeze-dried biotic2 sticks of 3g consumed daily for 28 days | Other | Arm 1, Test: freeze-dried B. lactis |
| Maltodextrin2 sticks of 3g consumed daily for 28 days | Other | Arm 2, Control: freeze-dried maltodextrin |
Primary outcome
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).
Time frame: From Baseline to Visit 4 (28 days).
4 secondary outcomes
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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: Between Week0 (V2), Week2 (V3), Week4 (V4) and Week5 (V5).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Gastro-intestinal Symptoms in Healthy Subjects
Active, not recruiting
The Impact of Postbiotic Supplementation on Tolerability and Physiological/Metabolic Parameters
Gastrointestinal Health
RecruitingPhase 4
Study to Assess Safety and Tolerability of KarXT With Administration of Antiemetics in Healthy Volunteers
Healthy Volunteers
Recruiting
Satiety, Microbiome, Appetite Regulation, and Tracking Energy Across Targeted Snacks: Chronic Study
Healthy Participants, Healthy Adult Subject
Recruiting
Effects of Probiotic Supplementation on Stress and Anxiety in Students
Stress, Anxiety
Active, not recruiting
Magnetic Resonance Imaging of the Brain and Stomach in Healthy Volunteers and Gastroparesis
Gastroparesis
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. This study is not recruiting at the moment.
Rim HASSOUNA, PhD study chair
Danone Research, Palaiseau, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Freeze-dried biotic and Maltodextrin in people with Gastro-intestinal Symptoms in Healthy Subjects, run by Danone Global Research & Innovation Center at 1 site in France.
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 11 inclusion and 20 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: finished, as of the sponsor's last update on 9 Aug 2024. 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 France. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: From Baseline to Visit 4 (28 days).). 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 9 Aug 2024.