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NCT Number: NCT07427914

Effectiveness and Safety of Benemix® in Constipation

The goal of this clinical trial is to find out whether the functional food Benemix® helps treat constipation in adults and whether it is safe to use.

The main questions this study aims to answer are:

Does Benemix® help improve bowel movement frequency and consistency in adults with constipation?

What medical problems, if any, do participants experience while taking Benemix®?

Adults with constipation will take Benemix® every day for 15 days. During the second week, participants will have either an in-person clinic visit or a telemedicine appointment for checkups and tests.

Participants will also receive follow-up phone calls to record:

* daily treatment adherence * signs and symptoms * the number of bowel movements each day.

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Key information

Conditions

Constipation - Functional

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adults (≥18 years old) who use Benemix® for the management of constipation.
Participants who are using the product for the first time.

Exclusion criteria

Pregnant or breastfeeding women.
Individuals with a diagnosis of severe gastrointestinal diseases, mental disorders, hemophilia, and/or cancer.
Individuals who have used laxatives within the last 7 days.

Treatment and study plan

Benemix®, a functional food composed of turmeric, onion, magnesium, and lactose-free, skimmed milk powder

Dietary Supplement

Benemix® is a functional food formulation designed to support intestinal health and relieve functional constipation in adults. It contains a combination of turmeric (Curcuma longa), onion (Allium cepa), magnesium, and lactose-free skimmed milk powder.

Participants will consume one oral serving of Benemix® once daily for 15 consecutive days. The product is provided as a powdered formulation that must be reconstituted in water or milk prior to consumption.

Benemix® differs from other dietary interventions by combining bioactive compounds from turmeric and onion, which have anti-inflammatory and digestive properties, with magnesium, known for its osmotic laxative effect. The lactose-free dairy base is intended to improve tolerability in individuals who are sensitive to lactose.

All participants will receive instructions on proper preparation and use of the product. Treatment adherence will be monitored through follow-up phone calls and daily symptom diaries.

Primary outcomes

Change in frequency of bowel movements

Time frame: From baseline (Day 0) to Day 15.

Number of spontaneous bowel movements per week recorded using a daily patient diary.

Unit of Measure: Number of bowel movements per week
Change in stool consistency measured by the Bristol Stool Form Scale (BSFS)

Time frame: From baseline (Day 0) to Day 15.

Stool consistency will be assessed using the Bristol Stool Form Scale (BSFS), a validated 7-point scale (Type 1 = separate hard lumps; Type 7 = entirely liquid). Types 3-4 represent normal stool consistency. Lower scores indicate harder stools; higher scores indicate looser stools.
Incidence of adverse events

Time frame: Throughout the 15-day intervention period.

Number and type of adverse events recorded during the 15-day intervention period, classified according to severity and relationship to the product.

Number of participants with adverse events

Study contacts

Contact information is provided by the study sponsor or research team.

Javier M Ceballos Rueda, PhD

CONTACT

[email protected]

+573174268448

Sponsors and collaborators

Lead sponsor

Universidad de Antioquia

Other

Registry information

Official study title

Evaluation of the Effectiveness and Safety of Benemix®, a Functional Food, in the Management of Constipation in Adults

Acronym: (Benemix-UdeA)

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Feb 23, 2026
Registry last updated: Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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