Clinical Efficacy, Treatment Efficacy, Drug Side Effect
Conditions
Keywords
Lubiprostone, Functional constipation, Adolescent, Children, Spontaneous Bowel Motions, Drug safety
Brief summary
The investigators will enroll subjects 8 - \< 18 years of age, fulfilling Rome IV criteria for functional constipation. Participants will be randomly assigned to either Lubiprostone treatment (study group), or the control group (will receive either lactulose or Bisacodyl tablets). safety and efficacy will be assessed.
Detailed description
The investigators will enroll 274 subjects who will be randomly divided equally into interventional and control groups. Participants and their parents/legal guardians will be instructed to administer the doses at least 5 hours apart with meals and a large volume of fluid. The control group will receive lactulose 1 mL/kg, once or twice daily (maximum 60 mL/day or Bisacodyl tablet (5 mg/tablet) in a dose of 2 tab/day for \< 12 years or 3 tab/day for \> 12 years. Both arms will receive the treatment for 12 weeks followed by 4 weeks follow-up after the end of treatment (week 16). Participants (and their guardians) will be instructed to regularly document the number of spontaneous bowel motions/week and to define their Bristol chart category for every bowel motion. In addition, the participants will be encouraged to contact the trial team if any adverse events appeared. This is in addition to regular visits at 0, 2, 8, 12 weeks for assessment of safety (efficacy will be assessed at weeks 8, 12, and 16).
Interventions
DRUGLubiprostone Pill
Oral pills for constipation (Lubiprostone) will be given in a dose range from 24 mcg once daily to 24 mcg twice daily according to the participant weight.
Lactulose Lactulose, or Duphalac syrup at a dose of 1 ml/kg once or twice daily (maximum 60 mL/day)
DRUGBisacodyl 5 MG
Bisacodyl tablet (5 mg/tablet) in a dose of 2 tab/day for \< 12 years or 3 tab/day for \> 12 years
Sodium Picosulfate 0.75% drops in a daily dose of 2.5-20 mg/day
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients assigned to lubiprostone will receive a dose based on their weight at the time of enrollment. patients weighing \<50 kg and ≥ 50 kg will be given lubiprostone at doses of 8 mg TID and 24 mg BID, respectively. Patients and their parents/legal guardians will be instructed to administer the doses at least 5 hours apart with meals and large volume of fluid. The control group will receive the conventional therapy (lactulose 1 mL/kg, once or twice daily (maximum 60 mL/day), or Bisacodyl tablet (5 mg/tablet) in a dose of 2 tab/day for \< 12 years or 3 tab/day for \> 12 years. Both arms will receive the treatment for 12 weeks followed by 4 weeks follow-up after the end of treatment (week 16).
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Patients 8 - \< 18 years of age who have a confirmed diagnosis of Pediatric functional constipation according to the Rome IV criteria, who give written informed consent personally or from their legal guardians. * Discontinuation of any medication affecting gastrointestinal (GI) motility at least 2 weeks before starting the treatment allocation. * Patient's daily diary that indicates an average of \< 3 weekly spontaneous bowel movements (SBMs), with ≥ 25% of SBMs involving at least some straining and/or a 5-point modified Bristol Stool Form Scale type 1 or 2. * Patients who completed the study protocol.
Exclusion criteria
1. If the patient's constipation is attributed to any of the following: physical, mental, or cognitive illness, inflammatory bowel disease, medication, anatomical, neurological, endocrine, or metabolic factors. 2. If the patient is a candidate for or underwent abdominal surgery, or has any condition other than constipation that could affect gastrointestinal motility or defecation. 3. Patients suffering from Hirschsprung's disease. 4. Patients experiencing any alarming signs e.g. unexplained significant weight loss. 5. Untreated fecal impaction at the time of enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary outcome | At study week 16. | Spontaneous bowel motions (SBM) ≥ 1 SBM/week increase in the frequency compared with baseline, and ≥ 3 SBMs/week for at least 8 weeks, including the last 4 study weeks and the 4 weeks of follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Early spontaneous bowel motions | First 48 hours after first drug dose. | Number of participants who experienced first SBM within 48 hours after dose initiation. |
| First dose response time | 1st week of treatment | The time between first dose of treatment and the first SBM. |
| Number of Spontaneous Bowel Motions/Week. | At study week Week 8, 12. | Number of Spontaneous Bowel Motions/Week. |
| Responders rate | At study week Week 8, 12, 16. | Responders rate at week 8, 12, 16. |
Countries
Egypt
Outcome results
None listed