Effects of pectin liquid on gastroesophageal reflux disease in children with cerebral palsy
| ISRCTN | ISRCTN19787793 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN19787793 |
| Secondary identifying numbers | N/A |
- Submission date
- 24/10/2007
- Registration date
- 29/10/2007
- Last edited
- 23/04/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Reiko Miyazawa
Scientific
Scientific
Department of Pediatrics and Developmental Medicine
Gunma University Graduate School
3-39-22
Showa-machi
Maebashi
Gunma
371-8511
Japan
| Phone | +81 27 220 8205 |
|---|---|
| rmiyazaw@med.gunma-u.ac.jp |
Study information
| Study design | Randomized single-blind controlled cross-over multicentre (2 hospitals) study. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(s) | 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. |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/03/2005 |
| Completion date | 30/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 2 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 18 |
| Key inclusion criteria | 1. Cerebral palsy 2. Age between 2 to 18 |
| Key exclusion criteria | Patients who received a surgical operation for GERD. |
| Date of first enrolment | 01/03/2005 |
| Date of final enrolment | 30/09/2007 |
Locations
Countries of recruitment
- Japan
Study participating centre
Department of Pediatrics and Developmental Medicine
Gunma
371-8511
Japan
371-8511
Japan
Sponsor information
Gunma University, Department of Pediatrics and Developmental Medicine (Japan)
University/education
University/education
3-39-22
Showa-machi
Maebashi
Gunma
371-8511
Japan
"ROR" |
https://ror.org/046fm7598 |
|---|
Funders
Funder type
University/education
The Gunma University Graduate School (Japan)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 16/04/2008 | Yes | No |
