Response to Supplement and Placebo in GERD

Beth Israel Lahey Health

Status: Completed

Conditions: Heartburn; Dyspepsia; Gastroesophageal Reflux Disease (GERD)

Treatments: Drug: Placebo; Behavioral: Expanded Interview; Behavioral: Standard Interview; Drug: Supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT01915173

2012P000409

IND 117358 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to investigate the effects of a widely available over the counter supplement marketed for heartburn symptoms on symptoms and health-related quality of life in patients with gastroesophageal reflux disease (GERD). This study is designed as a pilot trial to assess safety and feasibility and to provide preliminary estimates of effect sizes.

Enrollment: 24 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult humans age 18-80.
• Fluency in written and spoken English.
• Heartburn symptoms 3 or more days per week for the past month.

Exclusion criteria

• Individuals taking a proton pump inhibitor (PPI) or H2 receptor blocker with a dose change within 2 weeks of the initial study visit.
• Individuals with Crohns disease, systemic sclerosis, known active ulcer disease, gastric cancer, Barrett's esophagitis
• Significant pain or difficulty with swallowing
• Heavy alcohol use (defined by > 6 drinks/week for women and > 13 drinks/week for men)
• Concurrent pregnancy
• Dementia
• Uncontrolled psychiatric disease
• Individuals unable to complete a paper symptom diary for 6 of 7 days prior to their baseline visit
• Subjects whose symptoms are predominantly dyspeptic more than heartburn or reflux
• Subjects who have used homeopathy for GI symptoms or have received constitutional homeopathic treatment within the past 2 weeks
• Subjects taking herbal products or other supplements for GERD or dyspepsia related symptoms (includes peppermint oil)
• Subjects who have taken > 12 doses of NSAIDS within the prior 30 days (aspirin ≤ 325 mg daily is allowed)
• Subjects with lactose intolerance

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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24 participants in 4 patient groups, including a placebo group

Supplement + Expanded Interview

Experimental group

Description:

Supplement, 2 tablets sublingually 3 times a day for 2 weeks.

Treatment:

Behavioral: Expanded Interview

Drug: Supplement

Placebo + Standard Interview

Placebo Comparator group

Description:

Placebo, 2 tablets sublingually 3 times a day for 2 weeks.

Treatment:

Drug: Placebo

Behavioral: Standard Interview

Supplement + Standard Interview

Experimental group

Description:

Supplement, 2 tablets sublingually 3 times a day for 2 weeks.

Treatment:

Behavioral: Standard Interview

Drug: Supplement

Placebo + Expanded Interview

Placebo Comparator group

Description:

Placebo, 2 tablets sublingually 3 times a day for 2 weeks.

Treatment:

Drug: Placebo

Behavioral: Expanded Interview