Functional constipation Digestive System
Conditions
Interventions
The active intervention is a food supplement containing inulin (from chicory) powder, partially hydrolyzed guar gum, xanthan gum, a blend of acacia gum powder (Acacia seyal Delile, gummi) and dehydrat
Sponsors
Bromatech srl
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male and female subjects 2. Subjects of Caucasian ethnicity 3. Subjects aged between 18 and 64 years (extremes included)* 4. Subjects with functional constipation** 5. Subjects registered with national health service 6. Subjects certifying the truthfulness of the personal data disclosed to the Principal Investigator or designated personnel 7. Subjects able to understand the language used in the investigation centre and the information given by the Principal Investigator or designated personnel 8. Subjects able to respect the instructions given by the Principal Investigator or designated personnel as well as able to respect the study constraints and specific requirements 9. Subjects who commit not to change their daily routine or lifestyle during the study*** 10. Subjects on stable pharmacological therapy (except for the pharmacological therapy in the non-inclusion criteria) for at least one month without any changes expected or planned during the study 11. Subjects informed about the test procedures who have signed a consent form and privacy agreement. *If the subject is older than 50 years, they must have undergone a colonoscopy with a negative result within the previous 5 years **Assessed by the gastroenterologist using Rome IV criteria diagnostic criteria for functional constipation. To diagnose functional constipation, the individual must meet two or more of the following criteria for the last 3 months, with symptom onset at least 6 months prior to diagnosis: 1. Straining during more than ¼ (25%) of defecations 2. Lumpy or hard stools (Bristol Stool Form Scale 1-2) more than ¼ (25%) of defecations 3. Sensation of incomplete evacuation more than ¼ (25%) of defecations 4. Sensation of anorectal obstruction/blockage more than ¼ (25%) of defecations 5. Manual maneuvers to facilitate more than ¼ (25%) of defecations (e.g., digital evacuation, support of the pelvic floor) 6. Fewer than three spontaneous bowel movements per week 7. Loose stools are rarely present without the use of laxatives 8. Insufficient criteria for irritable bowel syndrome ***Subjects will keep a weekly diary where they will record their eating habits. This diary will be collected during the washout week and during the following weeks while taking the product.
Exclusion criteria
Exclusion criteria: 1. Subjects who do not meet the inclusion criteria 2. Subjects with any acute, chronic, or progressive disease or condition that may interfere with the study data or that the investigator considers dangerous to the subject or incompatible with the requirements of the study**** 3. Subjects participating or planning to participate in other clinical trials 4. Subjects who participated in a similar study without respecting an adequate washout period (at least 1 month) 5. Subjects that have food intolerances or food allergies to ingredients of the study product 6. Subjects under pharmacological treatments that are considered incompatible with the study requirement by the investigator ***** 7. Subjects who are currently using food supplement(s) and/or products with the same activity as the study product, or who haven't observed an adequate washout period (at least 1 month) 8. Subjects admitted to a health or social facility 9. Subjects planning a hospitalization during the study 10. Subjects not able to be contacted in case of emergency 11. Subjects deprived of freedom by administrative or legal decision or under guardianship 12. Subjects who have or have had a history of alcohol or drug addiction 13. Subjects with eating disorders (i.e. bulimia, psychogenic eating disorders, etc) 14. Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (for the women of childbearing potential). ****Including organic constipation or another chronic digestive condition that could confound the evaluation of constipation (e.g. inflammatory bowel disease, neoplasia, intestinal obstruction); constipation secondary to chronic conditions such as metabolic, endocrine or neurological diseases; alarm symptoms (e.g., fever, gastrointestinal bleeding, weight loss, anemia, abdominal mass); or any condition considered by the principal investigator to interfere with the study. Verification will be performed by the principal investigator. *****Including opioids, tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs), anticonvulsants, calcium channel blockers, iron salts, calcium salts, aluminum salts, diuretics. Verification will be performed by the principal investigator.
Countries
Italy
Contacts
Public ContactErminia;Roberta D’Ambrosio;Villa
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Outcome results
None listed