Clinical evaluation of the efficacy of a food supplement in improving the regularity of bowel movements

ISRCTN	ISRCTN30625880
DOI	https://doi.org/10.1186/ISRCTN30625880
Clinical Study Protocol Number	EC_ NT0000023/26
Study Code_Order	H.E.HU.HV.NMS00.060.03.00_NT0000171-26
Sponsor	Bromatech srl
Funder	Bromatech srl

Submission date: 13/03/2026
Registration date: 24/03/2026
Last edited: 20/03/2026

Recruitment status: No longer recruiting
Overall study status: Ongoing
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Edoardo Vincenzo Benedetto
Principal investigator

via F. Todaro 20/22, Rende (CS)
Rende
87036
Italy

Phone	+39 (0)9841735511
Email	nutratech@nutratechtesting.com

Dr Erminia D’Ambrosio
Scientific, Public

via F. Todaro 20/22, Rende (CS)
Rende
87036
Italy

Phone	+39 (0)9841735511
Email	erminia.dambrosio@nutratechtesting.com

Dr Roberta Villa
Public, Scientific

Viale Indipendenza, 11, Pavia (PV)
San Martino Siccomario
27100
Italy

Phone	+39 (0)38225504
Email	roberta.villa@complifegroup.com

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Blinded (masking used)
Control	Placebo
Assignment	Parallel
Purpose	Treatment, Efficacy
Scientific title	Clinical evaluation of the efficacy of a food supplement in improving the regularity of bowel movements: a randomized, double-blind, parallel-group, placebo-controlled study
Study objectives	The primary objective of this study is to evaluate the efficacy of the product in improving the regularity of bowel movements (increasing transit and motility) in subjects complaining of functional constipation. The secondary objective of this study is to evaluate the efficacy and pleasantness of the product as perceived by the subjects.
Ethics approval(s)	Approved 02/03/2026, International Ethics and Integrity Committee (Via Per Garbagnate 61, Lainate (MI), Lainate, 20045, Italy; +39 (0)3783037302; secretariat@ieicomittee.com), ref: Rif. IC0017 A
Health condition(s) or problem(s) studied	Functional constipation
Intervention	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 dehydrated pulp of the fruit of baobab powder (Adansonia digitata L., fructus), Malva (Malva sylvestris L., folium) dry extract, maltodextrin from corn, α-gluco-oligosaccharide (α-GOS) powder, corn starch, natural flavor, cross-linked sodium carboxymethyl cellulose, and citric acid, while the placebo contains maltodextrin from corn, natural flavor and citric acid. A restricted randomization list will be generated by an independent technician using the appropriate algorithm ("Wei’s urn") of the PASS 11 software (PASS, LLC, Kaysville, UT, USA) and stored in a secure location. The Principal Investigator or designated personnel will dispense the products according to the generated randomization list: half of the subjects will be supplied with the active product, while the other half will be supplied with the placebo. The study will be double-blind, meaning that subjects, the principal investigator and collaborators are kept masked to product assignment. The products will be supplied in the same packaging with no obvious differences between them. The study is structured into two phases: a preliminary phase lasting 3 months and a 35-day experimental phase, which includes a 1-week washout period and 1 week of baseline data collection, followed by 21 days of treatment. Three clinical visits are planned during the preliminary phase and three clinical visits during the experimental phase at T0 (baseline visit), T14 (follow-up visit, after 14 ± 2 days of treatment), and T21 (final visit, after 21 ± 2 days of treatment). Subjects take the assigned treatment for 21 days ± 2 days as follows: two sachets a day, one before breakfast and one before dinner. The product needs to be dissolved in water and drunk immediately or wait a few minutes and then be drunk.
Intervention type	Supplement
Primary outcome measure(s)	Number of bowel evacuations (n) measured using a diary to record each movement at baseline and after 14 and 21 days of product use Stool status measured using the Bristol Stool Form Scale (BSFS) (score from 1 to 7) at baseline and after 14 and 21 days of product use
Key secondary outcome measure(s)	Efficacy perceived and pleasantness of the product measured using self-evaluation questionnaire (polytomous question with four possible answers) at 14 and 21 days of product use
Completion date	25/09/2026

Eligibility

Participant type(s)
Age group	Adult
Lower age limit	18 Years
Upper age limit	64 Years
Sex	All
Target sample size at registration	66
Key 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.
Key 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.
Date of first enrolment	05/03/2026
Date of final enrolment	08/05/2026

Locations

Countries of recruitment

Italy

Study participating centre

Nutratech S.r.l.

Via Francesco Todaro, 20/22, Rende (CS)
Rende
87036
Italy

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan

Editorial Notes

13/03/2026: Study's existence confirmed by the International Ethics and Integrity Committee.