DyspepsiaNCT02863822
Study to Evaluate Dietary Modification in Patients With Functional Dyspepsia.
A study testing Low FODMAP Diet and Choose My Plate Diet in people with Dyspepsia and Dietary Modification, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of the low fermentable oligo-di-monosaccharides and polyols (FODMAP) diet in functional dyspepsia (FD). The investigators will compare education in the low FODMAP diet to a standard healthy diet for improving symptoms in FD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspepsia, Dietary Modification
- What is being tested?
- Low FODMAP Diet and Choose My Plate Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women 18 years and older
- Diagnosis of FD with either PDS or EPS as measured by Rome III Criteria
- Patients describing inadequate relief of dyspepsia symptoms
- Endoscopy performed in the last 3 years and negative for an organic cause for dyspeptic symptoms
- H pylori negative by non-invasive testing or biopsy. Patients with a history of successfully eradicated H pylori will be included if follow-up testing by stool antigen, urea breath testing, or biopsy is negative
- Celiac disease excluded by serologies or biopsy
Who cannot join
- Patients with IBS predominant symptoms that are not well controlled
- Patients with a diagnosis of GERD who have uncontrolled heartburn
- History of esophagitis, ulcer disease, or other organic upper GI disease, including a diagnosis of celiac disease, gastroparesis, or vascular disorders of the upper GI tract
- History of surgery involving the esophagus, stomach, or duodenum
- Known lactose intolerance, unless symptoms persist on a lactose free diet
- Known fructose intolerance unless symptoms persist on a fructose free diet
Show all 9Show fewer
- Patients undergoing active titration of any medications
- Pregnant or breastfeeding women
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068
About this study
Official title: A Prospective, Randomized, Investigator Blinded, Controlled Trial to Evaluate the Effectiveness of Dietary Modification in Patients With Functional Dyspepsia
The purpose of this study is to evaluate the effectiveness of the low fermentable oligo-di-monosaccharides and polyols (FODMAP) diet in functional dyspepsia (FD). The investigators will compare education in the low FODMAP diet to a standard healthy diet for improving symptoms in FD.
Read the detailed description
Functional Dyspepsia (FD) is defined by the Rome III criteria as bothersome postprandial fullness, early satiation, epigastric pain, or epigastric burning in the absence of structural or systemic disease that can explain the symptoms. These symptoms have been present for at least 3 months with symptom onset 6 months prior to the diagnosis.
The low fermentable oligo-di-monosaccharides and polyols (FODMAP) diet has been studied in irritable bowel syndrome (IBS) patients and has been shown to have modest benefit in a limited number of small studies. The diet is generally started by complete elimination of fructose, lactose, fructans, galactans, and polyols. Following symptom improvement, these groups are reintroduced one at a time while the patient monitors for symptoms.
Although the low FODMAP diet has never been formally studied in patients with functional dyspepsia, we have noted the FD patients report improvement in their symptoms on the diet. This improvement could be explained by reduction in duodenal and gastric distention with the low FODMAP diet or a change in the duodenal flora.
To date, there have been no randomized trials evaluating dietary modification in FD. The purpose of this study is to evaluate the efficacy of the low FODMAP diet in functional dyspepsia. The investigator's hypothesis is that the addition of the FODMAP diet to standard medical treatment will result in improved symptom control in patients with functional dyspepsia.
- Conditions
- Dyspepsia, Dietary Modification
- Being tested
- Low FODMAP Diet, Choose My Plate Diet
- Keywords
- Functional Dyspepsia, Low FODMAP, Dietary Modification
- Medical subject headings
- Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low FODMAP DietBehavioural
Subjects in the experimental arm, will be educated in the low fermentable oligo-di-monosaccharides and polyols (FODMAP) diet.
Choose My Plate DietBehavioural
Subjects in the active comparator arm will be educated in the ChooseMyPlate.gov Diet.
| Study group | Role | What they receive |
|---|---|---|
| Low FODMAP | Experimental | Subjects will be given dietary education in the low FODMAP diet, which they will continue for 4 weeks. Subjects will then followup with the dietician and subjects with a symptomatic response will be given instructions for reintroduction. Receives: Behavioral: Low FODMAP Diet |
| Choose My Plate | Active comparator | Subjects will receive dietary counseling in the choose my plate diet as defined by choosemyplate.gov. Subjects will also receive 2 dietician visits, 4 weeks apart. Receives: Behavioral: Choose My Plate Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self report of adequate relief
Self report of adequate relief of dyspepsia symptoms for the previous 7 days. This information will be collected at week 7. This measure is considered clinically relevant and has been tested for responsiveness in FD
Measured: Week 7 (after 4 weeks of diet modification)
Secondary outcomes (4)
Improvement in the NDI short form
The NDI short form is a validated questionnaire used to determine the severity of symptoms related to dyspepsia. It can be used to evaluate change over time.
Measured: Week 7 (after 4 weeks of diet modification)
Improvement in the Global Overall Symptom Scale
Measured: Week 7 (after 4 weeks of diet modification)
Continued Improvement in the Global Overall Symptom Scale
Measured: Week 10 (after low FODMAP reintroduction)
Continued Improvement in the NDI short form
The NDI short form is a validated questionnaire used to determine the severity of symptoms related to dyspepsia. It can be used to evaluate change over time.
Measured: Week 10 (after low FODMAP reintroduction)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Why it stopped: no patients enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for DyspepsiaStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hina Omar, MD, Principal investigator, Advocate Lutheran General HospitalMarc Fine, MD, Principal investigator, Advocate Lutheran General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02863822
- Sponsor's protocol ID
- 2015-203
- Status last verified
- Apr 2018
- First submitted
- 26 May 2016
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: No plan to make individual participant data available. Poster presentation, Manuscript publication, oral presentations are planned.
Publications
Staudacher HM, Lomer MC, Anderson JL, Barrett JS, Muir JG, Irving PM, Whelan K. Fermentable carbohydrate restriction reduces luminal bifidobacteria and gastrointestinal symptoms in patients with irritable bowel syndrome. J Nutr. 2012 Aug;142(8):1510-8. doi: 10.3945/jn.112.159285. Epub 2012 Jun 27.
PubMed 22739368Ong DK, Mitchell SB, Barrett JS, Shepherd SJ, Irving PM, Biesiekierski JR, Smith S, Gibson PR, Muir JG. Manipulation of dietary short chain carbohydrates alters the pattern of gas production and genesis of symptoms in irritable bowel syndrome. J Gastroenterol Hepatol. 2010 Aug;25(8):1366-73. doi: 10.1111/j.1440-1746.2010.06370.x.
PubMed 20659225Kerckhoffs AP, Samsom M, van der Rest ME, de Vogel J, Knol J, Ben-Amor K, Akkermans LM. Lower Bifidobacteria counts in both duodenal mucosa-associated and fecal microbiota in irritable bowel syndrome patients. World J Gastroenterol. 2009 Jun 21;15(23):2887-92. doi: 10.3748/wjg.15.2887.
PubMed 19533811Talley NJ, Dennis EH, Schettler-Duncan VA, Lacy BE, Olden KW, Crowell MD. Overlapping upper and lower gastrointestinal symptoms in irritable bowel syndrome patients with constipation or diarrhea. Am J Gastroenterol. 2003 Nov;98(11):2454-9. doi: 10.1111/j.1572-0241.2003.07699.x.
PubMed 14638348Talley NJ, Van Zanten SV, Saez LR, Dukes G, Perschy T, Heath M, Kleoudis C, Mangel AW. A dose-ranging, placebo-controlled, randomized trial of alosetron in patients with functional dyspepsia. Aliment Pharmacol Ther. 2001 Apr;15(4):525-37. doi: 10.1046/j.1365-2036.2001.00941.x.
PubMed 11284782Talley NJ, Locke GR, Saito YA, Almazar AE, Bouras EP, Howden CW, Lacy BE, DiBaise JK, Prather CM, Abraham BP, El-Serag HB, Moayyedi P, Herrick LM, Szarka LA, Camilleri M, Hamilton FA, Schleck CD, Tilkes KE, Zinsmeister AR. Effect of Amitriptyline and Escitalopram on Functional Dyspepsia: A Multicenter, Randomized Controlled Study. Gastroenterology. 2015 Aug;149(2):340-9.e2. doi: 10.1053/j.gastro.2015.04.020. Epub 2015 Apr 25.
PubMed 25921377Talley NJ, Verlinden M, Jones M. Quality of life in functional dyspepsia: responsiveness of the Nepean Dyspepsia Index and development of a new 10-item short form. Aliment Pharmacol Ther. 2001 Feb;15(2):207-16. doi: 10.1046/j.1365-2036.2001.00900.x.
PubMed 11148439
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Investigator Blinded, Controlled Trial to Evaluate the Effectiveness of Dietary Modification in Patients With Functional Dyspepsia
- ClinicalTrials.gov ID
- NCT02863822
- Acronym / sponsor ID
- 2015-203
- Conditions
- Dyspepsia, Dietary Modification
- Keywords
- Functional Dyspepsia, Low FODMAP, Dietary Modification
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no patients enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 11 Aug 2016 (estimated)
- Results
- Not posted in the source record
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 evaluate the effectiveness of the low fermentable oligo-di-monosaccharides and polyols (FODMAP) diet in functional dyspepsia (FD). The investigators will compare education in the low FODMAP diet to a standard healthy diet for improving symptoms in FD.
Detailed description
Functional Dyspepsia (FD) is defined by the Rome III criteria as bothersome postprandial fullness, early satiation, epigastric pain, or epigastric burning in the absence of structural or systemic disease that can explain the symptoms. These symptoms have been present for at least 3 months with symptom onset 6 months prior to the diagnosis.
The low fermentable oligo-di-monosaccharides and polyols (FODMAP) diet has been studied in irritable bowel syndrome (IBS) patients and has been shown to have modest benefit in a limited number of small studies. The diet is generally started by complete elimination of fructose, lactose, fructans, galactans, and polyols. Following symptom improvement, these groups are reintroduced one at a time while the patient monitors for symptoms.
Although the low FODMAP diet has never been formally studied in patients with functional dyspepsia, we have noted the FD patients report improvement in their symptoms on the diet. This improvement could be explained by reduction in duodenal and gastric distention with the low FODMAP diet or a change in the duodenal flora.
To date, there have been no randomized trials evaluating dietary modification in FD. The purpose of this study is to evaluate the efficacy of the low FODMAP diet in functional dyspepsia. The investigator's hypothesis is that the addition of the FODMAP diet to standard medical treatment will result in improved symptom control in patients with functional dyspepsia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low FODMAP | Experimental | Behavioral: Low FODMAP DietSubjects will be given dietary education in the low FODMAP diet, which they will continue for 4 weeks. Subjects will then followup with the dietician and subjects with a symptomatic response will be given instructions for reintroduction. |
| Choose My Plate | Active comparator | Behavioral: Choose My Plate DietSubjects will receive dietary counseling in the choose my plate diet as defined by choosemyplate.gov. Subjects will also receive 2 dietician visits, 4 weeks apart. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women 18 years and older
- Diagnosis of FD with either PDS or EPS as measured by Rome III Criteria
- Patients describing inadequate relief of dyspepsia symptoms
- Endoscopy performed in the last 3 years and negative for an organic cause for dyspeptic symptoms
- H pylori negative by non-invasive testing or biopsy. Patients with a history of successfully eradicated H pylori will be included if follow-up testing by stool antigen, urea breath testing, or biopsy is negative
Key exclusion criteria (9 listed)
- Patients with IBS predominant symptoms that are not well controlled
- Patients with a diagnosis of GERD who have uncontrolled heartburn
- History of esophagitis, ulcer disease, or other organic upper GI disease, including a diagnosis of celiac disease, gastroparesis, or vascular disorders of the upper GI tract
- History of surgery involving the esophagus, stomach, or duodenum
- Known lactose intolerance, unless symptoms persist on a lactose free diet
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 |
|---|---|---|
| Low FODMAP DietSubjects in the experimental arm, will be educated in the low fermentable oligo-di-monosaccharides and polyols (FODMAP) diet. | Behavioural | Low FODMAP |
| Choose My Plate DietSubjects in the active comparator arm will be educated in the ChooseMyPlate.gov Diet. | Behavioural | Choose My Plate |
Primary outcome
Self report of adequate relief
Time frame: Week 7 (after 4 weeks of diet modification)
Self report of adequate relief of dyspepsia symptoms for the previous 7 days. This information will be collected at week 7. This measure is considered clinically relevant and has been tested for responsiveness in FD
4 secondary outcomes
Improvement in the NDI short form
Time frame: Week 7 (after 4 weeks of diet modification)
Improvement in the Global Overall Symptom Scale
Time frame: Week 7 (after 4 weeks of diet modification)
Continued Improvement in the Global Overall Symptom Scale
Time frame: Week 10 (after low FODMAP reintroduction)
Continued Improvement in the NDI short form
Time frame: Week 10 (after low FODMAP reintroduction)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Background: PubMed 22739368Staudacher HM, Lomer MC, Anderson JL, Barrett JS, Muir JG, Irving PM, Whelan K. Fermentable carbohydrate restriction reduces luminal bifidobacteria and gastrointestinal symptoms in patients with irritable bowel syndrome. J Nutr. 2012 Aug;142(8):1510-8. doi: 10.3945/jn.112.159285. Epub 2012 Jun 27.
- Background: PubMed 20659225Ong DK, Mitchell SB, Barrett JS, Shepherd SJ, Irving PM, Biesiekierski JR, Smith S, Gibson PR, Muir JG. Manipulation of dietary short chain carbohydrates alters the pattern of gas production and genesis of symptoms in irritable bowel syndrome. J Gastroenterol Hepatol. 2010 Aug;25(8):1366-73. doi: 10.1111/j.1440-1746.2010.06370.x.
- Background: PubMed 19533811Kerckhoffs AP, Samsom M, van der Rest ME, de Vogel J, Knol J, Ben-Amor K, Akkermans LM. Lower Bifidobacteria counts in both duodenal mucosa-associated and fecal microbiota in irritable bowel syndrome patients. World J Gastroenterol. 2009 Jun 21;15(23):2887-92. doi: 10.3748/wjg.15.2887.
- Background: PubMed 14638348Talley NJ, Dennis EH, Schettler-Duncan VA, Lacy BE, Olden KW, Crowell MD. Overlapping upper and lower gastrointestinal symptoms in irritable bowel syndrome patients with constipation or diarrhea. Am J Gastroenterol. 2003 Nov;98(11):2454-9. doi: 10.1111/j.1572-0241.2003.07699.x.
- Background: PubMed 11284782Talley NJ, Van Zanten SV, Saez LR, Dukes G, Perschy T, Heath M, Kleoudis C, Mangel AW. A dose-ranging, placebo-controlled, randomized trial of alosetron in patients with functional dyspepsia. Aliment Pharmacol Ther. 2001 Apr;15(4):525-37. doi: 10.1046/j.1365-2036.2001.00941.x.
- Background: PubMed 25921377Talley NJ, Locke GR, Saito YA, Almazar AE, Bouras EP, Howden CW, Lacy BE, DiBaise JK, Prather CM, Abraham BP, El-Serag HB, Moayyedi P, Herrick LM, Szarka LA, Camilleri M, Hamilton FA, Schleck CD, Tilkes KE, Zinsmeister AR. Effect of Amitriptyline and Escitalopram on Functional Dyspepsia: A Multicenter, Randomized Controlled Study. Gastroenterology. 2015 Aug;149(2):340-9.e2. doi: 10.1053/j.gastro.2015.04.020. Epub 2015 Apr 25.
- Background: PubMed 11148439Talley NJ, Verlinden M, Jones M. Quality of life in functional dyspepsia: responsiveness of the Nepean Dyspepsia Index and development of a new 10-item short form. Aliment Pharmacol Ther. 2001 Feb;15(2):207-16. doi: 10.1046/j.1365-2036.2001.00900.x.
- Individual participant dataSharing planned: Yes. No plan to make individual participant data available. Poster presentation, Manuscript publication, oral presentations are planned.
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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.
Hina Omar, MD principal investigator
Advocate Lutheran General Hospital
Marc Fine, MD principal investigator
Advocate Lutheran General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low FODMAP Diet and Choose My Plate Diet in people with Dyspepsia and Dietary Modification, run by Wake Forest University Health Sciences 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 6 inclusion and 9 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: withdrawn, as of the sponsor's last update on 3 Oct 2024. 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Self report of adequate relief (time frame: Week 7 (after 4 weeks of diet modification)). 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 NCT02863822, which also lists 7 linked publications.
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 3 Oct 2024.