Condition category
Digestive System
Date applied
24/10/2007
Date assigned
29/10/2007
Last edited
23/04/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Reiko Miyazawa

ORCID ID

Contact details

Department of Pediatrics and Developmental Medicine
Gunma University Graduate School
3-39-22
Showa-machi
Maebashi
Gunma
371-8511
Japan
+81 27 220 8205
rmiyazaw@med.gunma-u.ac.jp

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Changing feeding style is an alternative therapy for decreasing GastroEsophageal Reflux (GER) -related symptoms. Use of thickeners is common and effective in decreasing frequent episodes of regurgitation or vomiting in infants, and in improving dysphagia in handicapped patients. We hypothesized that thickener is effective for GastroEsophageal Reflux Disease (GERD) in neurologically impaired children.

Ethics approval

This study was approved by the Human Investigation Committee of Gunma University on 17 February 2005. Informed consent was obtained from the mother of each subject.

Study design

Randomized single-blind controlled cross-over multicentre (2 hospitals) study.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Gastroesophageal Reflux Disease

Intervention

We enrolled 18 patients (16 male and 2 female) with cerebral palsy from 2 hospitals, Gunma University Hospital and Gunma Rehabilitation Centre for the Physically Handicapped Children. The average age of subjects was 11.7 ± 4.4 years old.

All patients received the enteral formula described below through a naso-gastric tube.

Phase 1: pH monitoring
The subjects were randomly allocated to the following 2 groups:

Group A (9 participants): Participants were fed with a high-pectin content diet (enteral formula: pectin liquid = 2:1 [v/v], intervention) and an enteral formula mixed with water added to a similar volume as the pectin liquid (non-pectin diet, control) in a cross-over manner.

Group B (9 participants): Participants were fed with a low-pectin content diet (enteral formula: pectin liquid = 3:1 [v/v], intervention) and a non-pectin diet (control) in a cross-over manner.

Esophageal pH of each participant was monitored over 48 hours while he/she was being fed with the formula described above.

Phase 2: Effects of pectin liquid on GERD symptoms

Group A: Nine patients were fed with a high-pectin content diet for 4 weeks (intervention), and with non-pectin diet (control) for 4 weeks in a cross-over manner.

Group B: Nine patients were fed with a low-pectin content diet for 4 weeks (intervention), and with non-pectin diet (control) for 4 weeks in a cross-over manner.

Intervention type

Drug

Phase

Not Specified

Drug names

Pectin

Primary outcome measures

The following were assessed by the esophageal pH monitoring:
1. The median values for the % time pH <4 at the lower and upper esophagus
2. Number of refluxes per day
3. Duration of longest reflux
4. Number of refluxes longer than 5 min

Secondary outcome measures

The following were assessed using the patient's chart filled by the nurse/clinician daily:
1. Number of episodes of vomiting per day
2. Number of gastric residue with bleeding
3. Volume of gastric residue
4. Cough score (cough and wheezing)
5. Frequency of oxygen use for dyspnea
6. Total volume of feeding per day
7. Time to return to school

Overall trial start date

01/03/2005

Overall trial end date

30/09/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Cerebral palsy
2. Age between 2 to 18

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

18

Participant exclusion criteria

Patients who received a surgical operation for GERD.

Recruitment start date

01/03/2005

Recruitment end date

30/09/2007

Locations

Countries of recruitment

Japan

Trial participating centre

Department of Pediatrics and Developmental Medicine
Gunma
371-8511
Japan

Sponsor information

Organisation

Gunma University, Department of Pediatrics and Developmental Medicine (Japan)

Sponsor details

3-39-22
Showa-machi
Maebashi
Gunma
371-8511
Japan

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

The Gunma University Graduate School (Japan)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/18412980

Publication citations

  1. Results

    Miyazawa R, Tomomasa T, Kaneko H, Arakawa H, Shimizu N, Morikawa A, Effects of pectin liquid on gastroesophageal reflux disease in children with cerebral palsy., BMC Gastroenterol, 2008, 8, 11, doi: 10.1186/1471-230X-8-11.

Additional files

Editorial Notes