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

NCT01882088 | Completed Phase 4 Results DMC

• 2 other identifiers: ION RAMSRussianAMS-1
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroesophageal Reflux Disease

Keywords

GERD; psyllium; Lower esophageal sphincter; Esophageal motility; Dietary fiber; Heartburn; gastroesophageal reflux; non-erosive gastroesophageal reflux disease

Outcome Measures

Primary Outcomes (1)

• Number of Gastroesophageal Refluxes

  Number of gastroesophageal refluxes registered with 24-hours esophageal pH-impedance on the 10th day of psyllium intake. Statistical data represent the results of the comparison of the data obtained on the day 10 of study (EOT) with the baseline characteristics provided in the specific section

  End of Treatment, on day 10 of psyllium intake

Secondary Outcomes (7)

• Acid Exposure Time

  End of Treatment, on day 10 of psyllium intake

• Number of Acid Gastroesophageal Refluxes

  End of Treatment, on day 10 of psyllium intake

• Number of Patients Experiencing Heartburn During 7 Days Prior the Day 10 of Psyllium Intake

  7 days prior to EOT

• Minimal Lower Esophageal Sphincter Pressure at Rest

  End of Treatment, on day 10 of psyllium intake

• Mean Resting Lower Esophageal Sphincter (LES) Pressure After 10 Water Swallows at the End of Treatment (the Day 10 of Psyllium Intake)

  End of Treatment, on day 10 of psyllium intake

Other Outcomes (2)

• Mean Lower Esophageal Sphincter Pressure (at Rest)

  End of Treatment, on day 10 of psyllium intake

• Stools Per Week

  7 days

Study Arms (1)

Mucofalk

EXPERIMENTAL

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

Drug: Mucofalk

Interventions

Mucofalk DRUG

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

Also known as: Psyllium

Mucofalk

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Russian Academy of Medical Sciences: lead
• Dr. Falk Pharma GmbH: collaborator

Study Sites (1)

Research Institute of Nutrition of Russian Academy of Medical Sciences

Moscow, 115446, Russia

Location

Related Publications (6)

• 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.

  PMID: 16817916 BACKGROUND

• 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.

  PMID: 11159879 BACKGROUND

• 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.

  PMID: 4124047 BACKGROUND

• 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.

  PMID: 15542505 BACKGROUND

• 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.

  PMID: 15591498 BACKGROUND

• 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.

  PMID: 16782525 BACKGROUND

Related Links

• Dr. Falk Pharma Gmbh

MeSH Terms

Conditions

Gastroesophageal Reflux; Heartburn

Interventions

Psyllium

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures

Limitations and Caveats

Absence of placebo control. Due to the nature of psyllium and its preparation, it is almost impossible to produce a comparator of similar viscosity, solubility in water, and taste. Relatively small group of patients

Results Point of Contact

• Title: Dr Sergey Morozov, Senior Reseracher, Dpt Gastroenterology and Hepatology
• Organization: Federal research Center of Nutrition and Biotechnology

morosoffsv@mail.ru

+74996131091

Study Officials

• Vasily A Isakov, MD,PhD,AGAF

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

  STUDY CHAIR

• Sergey Morozov, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, AGAF, Professor

Study Record Dates

• First Submitted: June 16, 2013
• First Posted: June 20, 2013
• Study Start: April 1, 2012
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 13, 2019
• Results First Posted: August 1, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: within 2 years after study completion
• Access Criteria: Official regulatory institutions request, official request by researchers or researchers organizations

Locations

RU (1)