Healthy Clinical Trial
— CONSYSTOfficial title:
Randomized, Placebo-controlled Double Blind Study to Evaluate the Effects of Dietary Supplementation With Short-chain Fructo-oligosaccharides (scFOS) on Nincrease in Stool Frequency in Constipated People
NCT number | NCT03707002 |
Other study ID # | PEC14513 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2015 |
Est. completion date | January 2017 |
Verified date | October 2018 |
Source | Syral |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study aims to evaluate the effects of short-chain fructo-oligosaccharides on the frequency and consistency of stools in subjects with functional constipation.
Status | Completed |
Enrollment | 186 |
Est. completion date | January 2017 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - functional constipation according to ROME III criteria with 3 or less than 3 stools per week - BMI between 18 and 32kg/m², limits included - Subjects who do not usually eat high-fibre foods - Subjects who do not usually consume foods siad "reduced in sugars" or "light" - Subjects who do not consume regularly pre- and probiotics in the form of dietary supplements Exclusion Criteria: - subjects presenting Irritable bowel syndrome - history of chronic GI disorders: crohn disease, ulcerative colitis,.... - treatments likely to influence GI sensitivity or motility (laxative, neuroleptics,...) - Antibiotic therapy in progress or in the past 8 weeks - medical history with impact on the study objectives as defined by investigator - known food allergy to one of the compounds of the study product |
Country | Name | City | State |
---|---|---|---|
France | Biofortis SAS | Saint-Herblain |
Lead Sponsor | Collaborator |
---|---|
Syral | Biofortis Mérieux NutriSciences, CreaBio Rhone-Alpes |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Heart rate | heart rate (bit per minute) | at baseline and at the last visit (after 6 weeks) | |
Other | systolic blood pressure | systolic blood pressure (mmHg) | at baseline and at the last visit (after 6 weeks) | |
Other | diastolic blood pressure | diastolic blood pressure (mmHg) | at baseline and at the last visit (after 6 weeks) | |
Other | Adverse event | Registration of all adverse events (number and severity of events) | 6 weeks | |
Primary | Stool frequency | Change in the number of stool per week between week at Baseline and the last week of supplementation | 6 weeks | |
Secondary | Stool consistency | Change in the stool consistency between Baseline and the end of supplementation, (Bristol Stool Scale 1 = hard to 7 = watery) | 6 weeks | |
Secondary | Frequency and severity of Gastrointestinal symptoms | Change in the frequency (number of occurrence) and severity (Likert scores from 0= no symptom to 7 =severe symptoms) individual Gastro-Intestinal symptoms (bloating, abdominal pain, flatulence,...) between Baseline and the end of supplementation | 6 weeks | |
Secondary | Anxiety and depression | Changes in anxiety and depression score between Baseline and the end of supplementation, measured by HAD score (Zigmond et al, 1983, from 0 to 21, score above 11 = anxiety or depression related pathology | 6 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06052553 -
A Study of TopSpin360 Training Device
|
N/A | |
Completed |
NCT05511077 -
Biomarkers of Oat Product Intake: The BiOAT Marker Study
|
N/A | |
Recruiting |
NCT04632485 -
Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
|
||
Completed |
NCT05931237 -
Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults
|
N/A | |
Terminated |
NCT04556032 -
Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women
|
N/A | |
Completed |
NCT04527718 -
Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers
|
Phase 1 | |
Completed |
NCT04065295 -
A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225
|
Phase 1 | |
Completed |
NCT04107441 -
AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects
|
Phase 1 | |
Completed |
NCT04998695 -
Health Effects of Consuming Olive Pomace Oil
|
N/A | |
Completed |
NCT01442831 -
Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects
|
Phase 1 | |
Terminated |
NCT05934942 -
A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood
|
Phase 1 | |
Recruiting |
NCT05525845 -
Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI
|
N/A | |
Completed |
NCT05515328 -
A Study in Healthy Men to Test How BI 685509 is Processed in the Body
|
Phase 1 | |
Completed |
NCT05030857 -
Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects
|
Phase 1 | |
Completed |
NCT04967157 -
Cognitive Effects of Citicoline on Attention in Healthy Men and Women
|
N/A | |
Recruiting |
NCT04494269 -
A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls
|
Phase 1 | |
Recruiting |
NCT04714294 -
Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT04539756 -
Writing Activities and Emotions
|
N/A | |
Recruiting |
NCT04098510 -
Concentration of MitoQ in Human Skeletal Muscle
|
N/A | |
Completed |
NCT03308110 -
Bioavailability and Food Effect Study of Two Formulations of PF-06650833
|
Phase 1 |