Completed

Digestive Health Supplement for Gastrointestinal Discomfort Relief in Adults

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Placebo

+ Active comparator

Dietary Supplement
Who is being recruted

From 20 to 60 Years
+23 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Placebo-Controlled
Interventional
Study Start: February 2024
See protocol details

Summary

Principal SponsorPharmanex
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 21, 2024

Actual date on which the first participant was enrolled.

This clinical trial is focused on evaluating the effectiveness of a digestive health supplement called Nu Biome in relieving symptoms of gastrointestinal discomfort, specifically bloating, in healthy adults. The study involves both male and female participants aged 20 to 60 who regularly experience digestive issues. The trial aims to provide insights into how well this supplement works compared to a placebo, which in this study is Crystal Light Raspberry Lemonade. Understanding the supplement's effectiveness could lead to better management of digestive discomfort for those affected. Participants in the trial are randomly assigned to either the supplement group or the placebo group for four weeks. They will record their daily bowel habits and any abdominal discomfort. The study also includes questionnaires on digestion-related quality of life and perceptions of bloating, taken at the beginning, at two weeks, and at the end of the study. Waist measurements and digital photographs are also taken at these intervals to track any changes. The study does not mention any risks, focusing instead on observing potential improvements in digestive health.

Official TitleA Single Centre, Double Blind, Placebo Controlled, Randomised Clinical Study Design in Healthy Subjects to Evaluate the Efficacy of a Digestive Health Supplement
NCT06680219
Principal SponsorPharmanex
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 20 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

9 inclusion criteria required to participate
Healthy male and female subjects aged 20 - 60 years old including a range of ethnicities.
Subject routinely experiences gastrointestinal discomfort, specifically bloating.
Subject has signed a written Informed Consent.
Willing to use the test article as instructed following the directions for usage provided by the sponsor.
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14 exclusion criteria prevent from participating
Subject is pregnant, nursing, or planning to become pregnant.
Treatment or medication containing sympathomimetics, antihistamines or corticosteroids in the seven days prior to study start.
Known allergies or hypersensitivity to dietary supplements, similar materials, or their ingredients including, but not limited to, hazelnuts, peanuts and pomegranates (family Lythraceae).
Subject has allergies or sensitivity (other than bloating/indigestion issues/GI discomfort) to the ingredients of the test meal.
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Placebo
The sample is Crystal Light Raspberry Lemonade Placebo sample Usage instructions for all groups: 2\. Mix 3 scoops of powder (with scoop provided) with 8-12 oz of water. Enjoy once daily (8-12 oz of water is approximately 236-354 mL of water).

Group II

Active Comparator
ACTIVE - Nu Biome (Formula #: 95001996; Batch #: EV24931) Active sample Usage instructions for all groups: 1\. Mix 3 scoops of powder (with scoop provided) with 8-12 oz of water. Enjoy once daily (8-12 oz of water is approximately 236-354 mL of water).

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

PCR Corp

Chelmsford, United KingdomOpen PCR Corp in Google Maps
CompletedOne Study Center
Digestive Health Supplement for Gastrointestinal Discomfort Relief in Adults | PatLynk