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OpenTrials
Completed

NCT Number: NCT06808867

Efficacy of Dietary Supplement in Subjects With Acid Reflux and/or Abdominal Bloating/Distention and GI Symptoms

This study was a prospective randomized clinical study. There was interventional treatment for a total of 8 weeks including a 2-week washout period. The subjects attended four appointments in the clinic throughout the duration of the study.

Study Primary Objective:

• To assess improvement in bloating symptoms

Study Secondary Objectives:

* To assess safety and tolerability of the formulation * To compare the time taken for perceptual improvement in bloating/distention * Enzyme blood assays * To assess quality of life indices

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Key information

Conditions

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

See Final Report

San Francisco, California, 94127, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Written informed consent to participate in the study.
  • Willingness to actively participate in the study and to come to the scheduled visits.
  • Female and/or male
  • From 18 to 85 years of age
  • Patients with self-reported abdominal bloating, abdominal distention, flatulence, and abdominal discomfort either after meals or not at least 3x a week for a minimum of the past 2 weeks

Exclusion criteria

  • Drug addicts, alcoholics.
  • AIDS, HIV-positive or infectious hepatitis
  • Diabetes mellitus
  • Disorders known to affect GI motility such as gastroparesis or amyloidosis.
  • Disorders with GI symptoms such as irritable bowel syndrome, inflammatory bowel disease and celiac disease
  • History of surgery known to alter the normal function of the GI tract.
  • Conditions which exclude participation or might influence the test reaction/evaluation.
  • Participation or being in the waiting period after participation in cosmetic and/or pharmaceutical studies pertaining to the test area.
  • Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years.
  • Documented allergies to cosmetic products and/or ingredients
  • Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) within the last 6 weeks prior to the start of the study and/or throughout the entire course of the study.
  • Oral steroids within the last 4 weeks prior to the start of the study and/or throughout the entire course of the study
  • Oral or systemic therapy with antibiotics within the last 3 months prior to the start of the study and/or throughout the entire course of the study
  • Subjects who were treated with biologics within the last 6 months prior to the start of the study and/or throughout the entire course of the study.
  • One of the following illnesses if not medicated: cardiovascular diseases, thyroid hyperfunction, asthma, hypertension.

Treatment and study plan

Placebo

Dietary Supplement

Eligible subjects will receive Placebo to take daily for six weeks

Dietary Supplement with Active Ingredient Blend

Dietary Supplement

Eligible subjects will receive Active supplement to take daily for six weeks

Primary outcomes

  1. Changes in Digestive Quality of Life Questionnaire (DQLQ) scores

    Time frame: from enrollment to end of study at 8 weeks

    To assess changes in scores related to bloating, diarrhea, constipation and heartburn on quality-of-life indicators, comparing active supplement to placebo group

  2. Changes in Symptom Severity Score (Diary)

    Time frame: from enrollment to end of study at 8 weeks

    Patients filled out the symptoms diary that had questionnaires of bowel habits. Abdominal pain and bloating were rated on a 100-point visual analogue scale with 0=none and 100=severe, comparing active supplement to placebo group

Secondary outcomes

  1. Changes in Gastrointestinal Short Form Questionnaire (GSFQ) Scores

    Time frame: from enrollment to end of study at 8 weeks

    To assess changes in gastrointestinal symptoms comparing active supplement to placebo group

  2. Changes in Stool Consistency (Bristol Stool Scale)

    Time frame: from enrollment to end of study at 8 weeks

    Daily stool consistency ratings will provide data on changes in bowel health and regularity. Average stool consistency scores will be compared across baseline, active treatment, and placebo phases.

Sponsors and collaborators

Lead sponsor

Olly, PBC

Industry

Registry information

Official study title

A 6-week Randomized, Double-blind, Comparative Clinical Study of the Efficacy of an Oral Product in Subjects With Acid Reflux and/or Abdominal Bloating/Distention and Gastrointestinal Symptoms

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 5, 2025
Registry last updated
Feb 5, 2025

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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