Irritable Bowel Syndrome Clinical Trial
Official title:
Study of a Management Strategy of Functional Bowel Disordes Related to Irritable Bowel Syndrome (IBS) With a Mixture of 8 Microbiotic Strains
Verified date | December 2021 |
Source | Larena SAS |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to determine the impact of a 10-day treatment with Lactichoc® on irritable bowel syndrome.
Status | Completed |
Enrollment | 189 |
Est. completion date | November 15, 2021 |
Est. primary completion date | November 15, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Having IBS symptomatology meeting the Rome IV criteria; - Having a IBS-SSS score =150 ; - In a state of general and mental health compatible with participation in the study ; - Agreeing to maintain their lifestyle during the study (same dietary and physical activity habits) ; - Willing to take stool samples; - Able and willing to participate in the research by complying with the protocol procedures, especially regarding the consumption of the study product; - Having electronic tools (computer, tablet...) and an internet connection, allowing him/her to fill out the self-questionnaires of the study online; - Affiliated to a social security system. Exclusion Criteria: - Have a history of hypersensitivity to any of the ingredients of the study product; - Under antibiotic treatment, or having stopped it for less than 14 days; - Under dietary supplementation (prebiotics or probiotics) or having stopped it for less than one month; - Having initiated or modified a background treatment for a comorbidity for less than one month, or planning to initiate it during the study, or planning to interrupt it during the study; - Having a lifestyle incompatible with the study as determined by the investigator; - Women who are pregnant or breastfeeding or who intend to become pregnant within the next 2 months; - Planning to travel extensively during the study period or unable to be contacted in case of emergency; - Psychologically or linguistically unable to understand and sign the informed consent; - Participating in another clinical trial or on an exclusion period from a previous clinical trial; - Under legal protection (guardianship, curatorship) or deprived of their rights following an administrative or judicial decision. |
Country | Name | City | State |
---|---|---|---|
France | General practitioners or gastroenterologists consulting in french private offices | Paris |
Lead Sponsor | Collaborator |
---|---|
PiLeJe |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Evolution of the stool microbiota composition | Metagenomic analysis | Between V1 (Day0) and V2 (Day10), then V2 (Day10) and Day30 | |
Primary | Evolution of the severity of functional bowel disorders | The severity of functional bowel syndrome is evaluated by Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) | 10 days | |
Secondary | Evolution of the severity of functional bowel disorders | The severity of functional bowel syndrome is evaluated by Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) | Between V2 (Day10) and Day30 (20 days) | |
Secondary | Description of the symptomatology | - 10-day average stool consistency according to the Bristol Stool Scale; | V1(Day0), V2 (Day10) and Day30 | |
Secondary | Description of the symptomatology | - 10-day average daily stool frequency; | V1(Day0), V2 (Day10) and Day30 | |
Secondary | Description of the symptomatology | - 10-day average abdominal pain score (Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) item 1b); | V1(Day0), V2 (Day10) and Day30 | |
Secondary | Description of the symptomatology | - 10-day global self-assessment of the impact of IBS symptoms (Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) item 4) | V1(Day0), V2 (Day10) and Day30 | |
Secondary | Description of quality of life | Evaluated by the GIQLI (Gastrointestinal Quality of Life Index) | V1(Day0), V2 (Day10) and Day30 | |
Secondary | Description of the anxiety-depressive disorders | Evaluated by the Hospital Anxiety and Depression (HAD) scale | V2 (Day10) | |
Secondary | Safety (tolerance to treatment) | Calculated with adverse events that may be observed during study period (descriptif results) | V2 (Day10) | |
Secondary | Treatment compliance | By counting treatments returned at the V2 visit | V2 (Day10) | |
Secondary | Global clinical evaluation | Evaluated by the investigator (V2) by a questionnaire | V2 (Day10) | |
Secondary | Global clinical evaluation | Evaluated by the patient (V2 and D30) by a questionnaire | V2 (Day10) and Day30 | |
Secondary | Evaluation of the satisfaction concerning the product by a questionnaire | Evaluated by the patient | Day30 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03720314 -
Microbiota Profiling in IBS
|
||
Recruiting |
NCT06166563 -
Exercise, Irritable Bowel Syndrome and Fibromyalgia
|
N/A | |
Recruiting |
NCT05985018 -
Traditional Dietary Advice Vs. Mediterranean Diet in IBS
|
N/A | |
Completed |
NCT04486469 -
Efficacy of Physiotherapy Techniques on Irritable Bowel Syndrome (IBS). Pilot Study.
|
N/A | |
Completed |
NCT06407609 -
Positive Outcomes of the Supplementation With Lecithin-based Delivery Form of Curcuma Longa and of Boswellia Serrata in IBS
|
N/A | |
Completed |
NCT04656730 -
Effect of STW5 (Iberogast ®) and STW5-II (Iberogast N®) on Transit and Tolerance of Intestinal Gas
|
Phase 4 | |
Completed |
NCT04145856 -
Combination of Alverine-simeticone and i3.1 Probiotic in IBS-D and IBS-M in Mexico
|
Phase 4 | |
Recruiting |
NCT04138225 -
The Ecological Role of Yeasts in the Human Gut
|
||
Active, not recruiting |
NCT03586622 -
One Year Home Monitoring and Treatment of IBS Patients
|
N/A | |
Completed |
NCT05207618 -
Utility of the Administration of Chesnut and Quebracho Extract for Irritable Bowel Syndrome Diarrhea Predominant
|
N/A | |
Not yet recruiting |
NCT06369753 -
Visible Abdominal Distension
|
N/A | |
Not yet recruiting |
NCT05157867 -
In Vivo Effects of Amylase Trypsin Inhibitors
|
N/A | |
Not yet recruiting |
NCT05100719 -
The Role of Irritable Bowel Syndrome in Lactose Intolerance (LION)
|
N/A | |
Recruiting |
NCT05001997 -
Effects of Lactose-free Dairy Products on Athletes With Irritable Bowel Syndrome
|
N/A | |
Recruiting |
NCT02953171 -
Probiotics in the Treatment of Irritable Bowel Syndrome
|
N/A | |
Completed |
NCT02977975 -
Lacto-fermented Sauerkraut in the Treatment of Irritable Bowel Syndrome
|
N/A | |
Completed |
NCT03266068 -
Epidemiology and Pathophysiology of Post-Infectious Functional GI Disorders
|
||
Completed |
NCT03318614 -
Bifidobacterium Infantis M-63 Improves Mental Health in Irritable Bowel Syndrome Developed After a Major Flood Disaster
|
Phase 2/Phase 3 | |
Completed |
NCT02980406 -
The Role of FODMAPs in Upper GI Effects, Colonic Motor Activity and Gut-brain Signaling at the Behavioral Level
|
N/A | |
Recruiting |
NCT02242175 -
Efficacy of Hydrogen Breath Test in the Patients With Irritable Bowel Syndrome
|
N/A |