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

Not Applicable

Completed

• Conditions: Healthy

• Registration Number: NCT06808867
• Lead Sponsor: Olly, PBC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-25
• Primary Completion: 2024-04-15
• Study Completion: 2024-04-15
• Status Verified: 2025-01
• Study First Submitted: 2025-01-30
• Study First Submitted QC: 2025-01-30
• Last Update Submitted: 2025-01-30
• Study First Posted: 2025-02-05
• Last Update Posted: 2025-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in Digestive Quality of Life Questionnaire (DQLQ) scores	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
Changes in Symptom Severity Score (Diary)	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 Outcome Measures

Name	Time	Method
Changes in Gastrointestinal Short Form Questionnaire (GSFQ) Scores	from enrollment to end of study at 8 weeks	To assess changes in gastrointestinal symptoms comparing active supplement to placebo group
Changes in Stool Consistency (Bristol Stool Scale)	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.

Trial Locations

Locations (1)

See Final Report; 🇺🇸 San Francisco, California, United States