Phase IV Study of the Impact of Dietary Fibers on Symptoms and Esophageal Motility in Patients With Non-erosive GERD

NCT ID: NCT01882088

Last Updated: 2019-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2016-12-31

Brief Summary

Gastroesophageal reflux disease (GERD) is a chronic condition, which may significantly decrease patients' quality of life due to the typical symptoms - heartburn and regurgitation. These are caused by increasing number of transient lower esophageal sphincter relaxations, regularly recurring reflux of gastric content into oesophagus, acidification of the esophagus and consequent esophageal mucosa damage. In addition, an important role is played by the increase in production of hydrochloric acid in the stomach, the slowdown in the evacuation of the contents from the stomach and increase of gastric and intra-abdominal pressure. All of these factors may depend on the patient's diet.

Theoretical premises of the positive influence of including dietary fiber on the course of gastroesophageal reflux disease may be the fact that dietary fiber may absorb nitric oxide (NO) containing in food, which in turn has relaxing effects on the lower esophageal sphincter. In addition, fiber deficiency has been shown to be associated with increased chance of developing hiatal hernia, which is associated with greater risk of the disease manifestations. There is lack of data to confirm that dietary interventions like higher dietary fiber intake may lead to lower frequency of GERD symptoms and influence objective criteria (those, obtained during esophageal pH-impedance (here and further: pH - pondus hydrogenii, i.e. quantity of hydrogen, a scale to measure acidity of a solution) recording and high resolution esophageal manometry).

Mucofalk® is a drug of plant origin, consisting of a shell seeds of Plantago ovata (ispaghula, psyllium). High content of mucuses in the composition of psyllium seed allows it to include to group of soft food fibers, which has fundamental value for the appointment of a drug at a number of diseases, when, for example, the use of coarse food fibres not recommended or contraindicated.

Mucofalk is the registered medicinal (registration number of the Russian State register of medicines P N014176/01, registration date 14.07.2008, manufacturer: Lozan Pharma Gesellschaft mit beschränkter Haftung (GmbH), packager: Dr. Falk Pharma GmbH, Germany). Recommended dosage and administration: orally, adults and children over 12 years - 1 pack. 2-6 times a day. Before use, the contents of 1 packet poured in a glass, in which slowly poured with cold water (150 ml), stir and drink immediately. Then drink another glass of liquid.

Detailed Description

During the study 14-days screening period is provided to evaluate H.pylori and endoscopic status of the patient and to confirm the presence of dietary fiber deficiency (based on standard computerized dietary questionnaire). On the baseline physical examination, GERD-Q questionnaire, GERD symptom severity scale (by Likert), Bristol stool scale, high resolution esophageal manometry and 24-hours esophageal pH-impedance studies are to be provided. Since baseline, up to day 10 Mucofalk 15 g/day in three times a day (TID) regimen is to be given. All the patient will receive standardized menu. Repeat evaluation of symptoms, high resolution esophageal manometry and 24-hours esophageal pH-impedance are to be done at the day 10 of the study.

Conditions

Gastroesophageal Reflux Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mucofalk

Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal

Group Type: EXPERIMENTAL

Mucofalk

Intervention Type: DRUG

Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal

Interventions

Mucofalk

Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal

Intervention Type: DRUG

Other Intervention Names

Psyllium

Eligibility Criteria

Inclusion Criteria

• Clinical diagnosis of non-erosive form of Gastroesophageal Reflux disease
• Dietary fiber deficiency by dietary questionnaire
• pathological gastroesophageal reflux by 24-hours esophageal pH-impedance examination
• willingness to participate (signed informed consent)

Exclusion Criteria

• presence of esophageal mucosal damages (esophagitis) by endoscopic evaluation
• gastrointestinal surgery in anamnesis
• current pregnancy or breast-feeding
• known hypersensitivity to Mucofalk or its components

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr. Falk Pharma GmbH

INDUSTRY

Sponsor Role: collaborator

Russian Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Vasily Isakov

MD, PhD, AGAF, Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vasily A Isakov, MD,PhD,AGAF

Role: STUDY_CHAIR

Fed. Research Center of Nutrition and Biotechnology, Gastroenterology&Hepatology

Sergey Morozov, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fed. Research Center of Nutrition and Biotechnology, Gastroenterology&Hepatology

Locations

Research Institute of Nutrition of Russian Academy of Medical Sciences

Moscow, , Russia

Countries

Russia

References

Ronkainen J, Aro P, Storskrubb T, Lind T, Bolling-Sternevald E, Junghard O, Talley NJ, Agreus L. Gastro-oesophageal reflux symptoms and health-related quality of life in the adult general population--the Kalixanda study. Aliment Pharmacol Ther. 2006 Jun 15;23(12):1725-33. doi: 10.1111/j.1365-2036.2006.02952.x.

Reference Type: BACKGROUND

PMID: 16817916 (View on PubMed)

Terry P, Lagergren J, Ye W, Wolk A, Nyren O. Inverse association between intake of cereal fiber and risk of gastric cardia cancer. Gastroenterology. 2001 Feb;120(2):387-91. doi: 10.1053/gast.2001.21171.

Reference Type: BACKGROUND

PMID: 11159879 (View on PubMed)

Burkitt DP, James PA. Low-residue diets and hiatus hernia. Lancet. 1973 Jul 21;2(7821):128-30. doi: 10.1016/s0140-6736(73)93067-5. No abstract available.

Reference Type: BACKGROUND

PMID: 4124047 (View on PubMed)

Nilsson M, Johnsen R, Ye W, Hveem K, Lagergren J. Lifestyle related risk factors in the aetiology of gastro-oesophageal reflux. Gut. 2004 Dec;53(12):1730-5. doi: 10.1136/gut.2004.043265.

Reference Type: BACKGROUND

PMID: 15542505 (View on PubMed)

El-Serag HB, Satia JA, Rabeneck L. Dietary intake and the risk of gastro-oesophageal reflux disease: a cross sectional study in volunteers. Gut. 2005 Jan;54(1):11-7. doi: 10.1136/gut.2004.040337.

Reference Type: BACKGROUND

PMID: 15591498 (View on PubMed)

Karamanolis G, Tack J. Nutrition and motility disorders. Best Pract Res Clin Gastroenterol. 2006;20(3):485-505. doi: 10.1016/j.bpg.2006.01.005.

Reference Type: BACKGROUND

PMID: 16782525 (View on PubMed)

Related Links

http://www.drfalkpharma.ru/about_us.html

Dr. Falk Pharma Gmbh

Other Identifiers

RussianAMS-1

Identifier Type: OTHER

Identifier Source: secondary_id

ION RAMS

Identifier Type: -

Identifier Source: org_study_id