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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
Results in http://www.ncbi.nlm.nih.gov/pubmed/18412980
Publication citations
-
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.