High fibre diet and low dose lincomycin for chronic constipation
| ISRCTN | ISRCTN33023013 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33023013 |
| Secondary identifying numbers | N/A |
- Submission date
- 13/01/2011
- Registration date
- 16/02/2011
- Last edited
- 16/02/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Luis Maria Bustos Fernandez
Scientific
Scientific
Echeverria 2771
CABA
1428
Argentina
| lbustos@arnetbiz.com.ar |
Study information
| Study design | Randomised double-blind placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | A controlled pilot study on the efficacy of a high fibre diet and a low dose lincomycin for chronic constipation |
| Study objectives | Assess the synergistic short term, low dose, preparatory action of a poorly absorbable antibiotic on chronic constipated patients on a high fibre diet. |
| Ethics approval(s) | This was a very small pilot observational study started in 1996 and finalised 1 year later. At the time of this pilot study, there was an exogenous improvised board named simply by the principal investigator and the ethics board that met gave only verbal approval. Since then, this board has dissolved and unfortunately records are not available. |
| Health condition(s) or problem(s) studied | Chronic constipation |
| Intervention | The study design determined a 15-day run-in phase without any drug or rescue laxatives and a 21-day controlled treatment period. On the first day of the controlled treatments period (Day 0) enrolled patients were randomised to an initial 10 day low dose lincomycin (0.5 g/d) or to placebo. During the 21 day treatment period, the diet of all patients was supplemented by 12 g of crude fibre (All Bran Kellog). Patients were assigned a number on accordance to a validated 10 point Visual Analogue Scale (VAS) of symptom severity (0 = very severe, 10 = asymptomatic). Post-hoc, we examined the proportion of patients that exhibited marked improvement in the efficacy parameters after the 21 day treatments. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Lincomycin |
| Primary outcome measure | Difference between treatments in the mean bowel frequency, straining, stool consistency and pain during defecation at baseline (Day 0) and by the end of treatment period (Day 21). |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 05/09/1996 |
| Completion date | 15/04/1997 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 30 patients |
| Key inclusion criteria | 1. Meet Rome II diagnostic criteria for chronic constipation characterised by: 1.1. A frequency of less than or equal to two bowel movements/week 1.2. Hard stool 1.3. Straining with occasional pain in more than 25% of bowel movements 2. Aged over 18 years, either sex |
| Key exclusion criteria | 1. Cardiac, pulmonary, renal, liver failure 2. Abnormal blood chemistries 3. Known antibiotic allergies In patients who were younger than 50 years and had no other complaint than chronic constipation and the physical examination and routine body chemistries were normal, it was assumed the diagnostic of functional constipation and no special gastrointestinal exams were performed. Patients greater than or equal to 50 years or with lower gastrointestinal bleeding underwent colon radiology or colonoscopy to rule out organic colorectal disease. |
| Date of first enrolment | 05/09/1996 |
| Date of final enrolment | 15/04/1997 |
Locations
Countries of recruitment
- Argentina
Study participating centre
Echeverria 2771
CABA
1428
Argentina
1428
Argentina
Sponsor information
Institute of Gastroenterology (Instituto de Gastroenterologia) (Argentina)
Research organisation
Research organisation
Echeverria 2771
CABA
1428
Argentina
| lbusto@arnetbiz.com.ar |
Funders
Funder type
Research organisation
Institute of Gastroenterology (Instituto de Gastroenterologia) (Argentina)
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 |
