Gastroesophageal Reflux Disease (GERD)NCT01915173
Response to Supplement and Placebo in GERD
A study testing Supplement, Expanded Interview and Standard Interview in people with Gastroesophageal Reflux Disease (GERD) and Heartburn, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastroesophageal Reflux Disease (GERD), Heartburn, Dyspepsia
- What is being tested?
- Supplement, Expanded Interview and Standard Interview
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Apr 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult humans age 18-80.
- Fluency in written and spoken English.
- Heartburn symptoms 3 or more days per week for the past month.
Who cannot join
- 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
Show all 13Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
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.
- Conditions
- Gastroesophageal Reflux Disease (GERD), Heartburn, Dyspepsia
- Being tested
- Supplement, Placebo, Expanded Interview, Standard Interview
- Keywords
- Gastroesophageal reflux disease (GERD), Heartburn, Dyspepsia
- Medical subject headings
- Gastroesophageal Reflux, Heartburn, Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SupplementDrug
Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C
PlaceboDrug
Lactose tablets
Expanded InterviewBehavioural
Standard InterviewBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Supplement + Expanded Interview | Experimental | Supplement, 2 tablets sublingually 3 times a day for 2 weeks. Receives: Drug: Supplement; Behavioral: Expanded Interview |
| Placebo + Standard Interview | Placebo comparator | Placebo, 2 tablets sublingually 3 times a day for 2 weeks. Receives: Drug: Placebo; Behavioral: Standard Interview |
| Supplement + Standard Interview | Experimental | Supplement, 2 tablets sublingually 3 times a day for 2 weeks. Receives: Drug: Supplement; Behavioral: Standard Interview |
| Placebo + Expanded Interview | Placebo comparator | Placebo, 2 tablets sublingually 3 times a day for 2 weeks. Receives: Drug: Placebo; Behavioral: Expanded Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Number of Participants Experiencing a Serious Adverse Event
Serious adverse events (as defined by the FDA) are events that are potentially life-threatening or result in death, hospitalization, an emergency room visit, disability or permanent damage, a congenital abnormality, require intervention to prevent permanent impairment, or seriously jeopardizes a patient's health.
Measured: 2 week follow-up
Secondary outcomes (2)
Number of Subjects With a 50% or Greater Decrease in GERD Symptom Severity
Average daily GERD symptom severity during the last 7 days of the study was compared to average daily GERD symptom severity at baseline using daily study diary entries. GERD symptom severity for each day was based on the sum of scores assessing the severity of daytime heartburn, nighttime heartburn, and acid reflux each on a 0-4 point scale (none, mild, moderate, severe, very severe). Higher scores signify worse symptoms. The number of subjects with a 50% or greater decrease in GERD symptom severity from baseline to end of study in each group was calculated.
Measured: Second week of the trial compared to pre-trial baseline
GERD Health-Related Quality of Life at Follow-up
The GERD Health-Related Quality of Life (GERD-HRQL) scale is a validated instrument assessing GERD-specific health-related quality of life using 10 questions, each on a 0-5 point scale. Scale range is 0-50 with higher numbers signifying worse quality of life.
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2013 (estimated)
- Study startJun 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux Disease (GERD)Studies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gloria Y. Yeh, Beth Israel Deaconess Medical Center
- Investigators
- Michelle Dossett, MD, PhD, MPH, Study director, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01915173
- Sponsor's protocol ID
- 2012P000409
- Other IDs
- IND 117358
- Status last verified
- Dec 2016
- First submitted
- 30 Jul 2013
- Last updated
- 29 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Dossett ML, Mu L, Davis RB, Bell IR, Lembo AJ, Kaptchuk TJ, Yeh GY. Patient-Provider Interactions Affect Symptoms in Gastroesophageal Reflux Disease: A Pilot Randomized, Double-Blind, Placebo-Controlled Trial. PLoS One. 2015 Sep 30;10(9):e0136855. doi: 10.1371/journal.pone.0136855. eCollection 2015.
PubMed 26422466
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response to Supplement and Placebo in GERD
- ClinicalTrials.gov ID
- NCT01915173
- Acronym / sponsor ID
- 2012P000409
- Conditions
- Gastroesophageal Reflux Disease (GERD), Heartburn, Dyspepsia
- Keywords
- Gastroesophageal reflux disease (GERD), Heartburn, Dyspepsia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 2 Aug 2013 (estimated)
- Results
- Posted 29 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Supplement + Expanded Interview | Experimental | Drug: Supplement, Behavioral: Expanded InterviewSupplement, 2 tablets sublingually 3 times a day for 2 weeks. |
| Placebo + Standard Interview | Placebo comparator | Drug: Placebo, Behavioral: Standard InterviewPlacebo, 2 tablets sublingually 3 times a day for 2 weeks. |
| Supplement + Standard Interview | Experimental | Drug: Supplement, Behavioral: Standard InterviewSupplement, 2 tablets sublingually 3 times a day for 2 weeks. |
| Placebo + Expanded Interview | Placebo comparator | Drug: Placebo, Behavioral: Expanded InterviewPlacebo, 2 tablets sublingually 3 times a day for 2 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult humans age 18-80.
- Fluency in written and spoken English.
- Heartburn symptoms 3 or more days per week for the past month.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SupplementAbies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C | Drug | Supplement + Expanded Interview, Supplement + Standard Interview |
| PlaceboLactose tablets | Drug | Placebo + Expanded Interview, Placebo + Standard Interview |
| Expanded Interview | Behavioural | Placebo + Expanded Interview, Supplement + Expanded Interview |
| Standard Interview | Behavioural | Placebo + Standard Interview, Supplement + Standard Interview |
Primary outcome
Safety - Number of Participants Experiencing a Serious Adverse Event
Time frame: 2 week follow-up
Serious adverse events (as defined by the FDA) are events that are potentially life-threatening or result in death, hospitalization, an emergency room visit, disability or permanent damage, a congenital abnormality, require intervention to prevent permanent impairment, or seriously jeopardizes a patient's health.
2 secondary outcomes
Number of Subjects With a 50% or Greater Decrease in GERD Symptom Severity
Time frame: Second week of the trial compared to pre-trial baseline
GERD Health-Related Quality of Life at Follow-up
Time frame: Two weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26422466Dossett ML, Mu L, Davis RB, Bell IR, Lembo AJ, Kaptchuk TJ, Yeh GY. Patient-Provider Interactions Affect Symptoms in Gastroesophageal Reflux Disease: A Pilot Randomized, Double-Blind, Placebo-Controlled Trial. PLoS One. 2015 Sep 30;10(9):e0136855. doi: 10.1371/journal.pone.0136855. eCollection 2015.
- study manuscriptLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Dossett, MD, PhD, MPH study director
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supplement, Expanded Interview and Standard Interview in people with Gastroesophageal Reflux Disease (GERD) and Heartburn, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety - Number of Participants Experiencing a Serious Adverse Event (time frame: 2 week follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01915173, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2017.