Functional constipation in children
Conditions
Interventions
Phase I, 12 to 17 years,low dose test group:Test drug 1.5g (3 bags) / time, given orally 2 times / day for 8 weeks
Stage I, the low-dose placebo group for subjects aged 12 to 17 years:Simulation agent 1.5g (3 bags) / time, orally twice / day, continuously for 8 weeks
Stage I, high-dose test group for subjects aged 12 to 17 years:Test drug 3g (6 bags), orally twice a day for 8 weeks
Stage I, high-dose placebo group for subjects aged 12 to 17 years:Simulation agent 3g (6 bags), orally twice a day for 8 weeks
Phase, age 6 to 11 ,,low dose test group:Test drug 1.5g (3 bags) / time, given orally 2 times / day for 8 weeks
Phase, the low-dose placebo group for subjects aged 6 to 11 years:Simulation agent 1.5g (3 bags) / time, orally twice / day, continuously for 8 weeks
Phase, age 6 to 11 ,high dose test group:Test drug 3g (6 bags), orally twice a day for 8 weeks
Phase, the high-dose placebo group for subjects aged 6 to 11 years:Simulation agent 3g (6 bags), orally twice a day for 8 weeks
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Age
6 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Age 6-17 years old (6 years old =18kg; 3. Clinically diagnosed as functional constipation, which meets the diagnostic criteria of Rome; 4. At the screening visit and at the end of the introduction period, the average SBM was 2 times / week; 5. Subjects under 8 years of age shall have their guardian consent and sign the informed consent form; subjects aged 8 to 17 years and their guardians shall agree and sign the informed consent form voluntarily.
Exclusion criteria
Exclusion criteria: 1. stool impaction occurs within 3 days before randomization, and is not removed after active treatment; 2. The potential organic causes of constipation in the subjects, including but not limited to: celiac disease, pediatric intestinal obstruction, spina bifida, cystic fibrosis, and pseudoobstruction; 3. constipation caused by significant developmental retardation associated with muscle, skeletal or neurological diseases and thus affecting gastrointestinal function; 4. Constipation secondary to endocrine, metabolic, nerve-spinal cord injury, multiple sclerosis or drug factors (such as urolithiasis, irritable bowel syndrome, ureteral junction stenosis, hypothyroidism, etc.); 5. Subjects with autoimmune diseases (such as systemic sclerosis) or intestinal defects (e. g., anorectal malformation, congenital megacolon, colonic weakness, macrorectum, etc.); 6. Severe malnutrition, rickets, or other serious systemic diseases such as cardiovascular disease, brain (such as cerebral palsy), liver, kidney and hematopoietic system (such as sickle cell disease); 7. People with a history of severe mental illness, such as bipolar disorder, schizophrenia, major depression, or autism spectrum disorder; 8. A partial gastrointestinal resection performed at any time prior to screening; or surgery on abdominal, pelvic or retroperitoneal structures within 6 months before screening; or appendectomy or cholecystectomy performed within 60 days prior to screening; or other major surgery within 30 days prior to screening; or sacral nerve stimulation (SNS), or sequential controlled enema (ACE) subjects by cecostomy or appendicestomy; 9. Repeated or unknown fever in the past one month; 10. Use of drugs (including Chinese herbal medicine, chemical drugs, biological drugs), and non-drug therapy such as acupuncture and massage; or drugs known to affect gastrointestinal motility such as opioids (such as codeine), calcium, iron, clonidine, anticholindrugs (e. g. atropine), non-potassium diuretics within 1 week before screening; 11. Allergy to raw and excipients of bifidobacteria or a previous history of allergy to microecology, or allergy to a variety of foods / drugs (subjects with severe allergies), or a previous history of allergy to cloplug; 12. having difficulty swallowing and unable to take drugs on time; 13. Participated in other interventional clinical studies within 4 weeks before screening; 14. Other circumstances considered by the investigator that are not suitable to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in mean weekly number of voluntary bowel movements (SBM) during treatment from weeks 4 to 8.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in mean weekly SBM sessions during weeks 1 to 8;Change from baseline in mean weekly SBM times during treatment in weeks 2-8;Change from baseline in mean weekly SBM times during treatment in weeks 3-8;Change from baseline in the average number of complete voluntary defecation (CSBM) per week from weeks 1 to 8;; Change from baseline in the average number of complete voluntary defecation (CSBM) per week from weeks 2 to 8; Change from baseline in the average number of complete voluntary defecation (CSBM) per week from weeks 3to 8;;Change from baseline in the average number of complete voluntary defecation (CSBM) per week from weeks 4to 8;; Change of weekly SBM times from baseline;;Change from baseline in weekly CSBM times;Time from treatment initiation to first SBM;Time from treatment initiation to first CSBM; | — |
Countries
China
Contacts
Public ContactLi Zailing
Peking University Third Hospital
Outcome results
None listed