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Prospective self-controlled multi-center clinical study on the efficacy of wheat cellulose in the treatment of functional constipation in children and changes in intestinal flora

Prospective self-controlled multi-center clinical study on the efficacy of wheat cellulose in the treatment of functional constipation in children and changes in intestinal flora

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084125
Enrollment
Unknown
Registered
2024-05-10
Start date
2024-01-14
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

functional constipation

Interventions

Test group:Oral treatment with wheat cellulose granules

Sponsors

Children’s hospital of Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Gender unlimited, age 6-12 years old, outpatient 2. It meets the diagnostic criteria of Rome IV functional constipation in children. (Patients with constipation whose main symptoms are reduced frequency of defecation and dry stool are included as far as possible) 3. In the past 1 week, no drugs have been used to affect gastrointestinal motility and treat constipation. Have not used wheat cellulose, compound polyethylene glycol, etc 4. No serious metabolic diseases, no serious cardiovascular, cerebrovascular, lung, liver, kidney and other chronic diseases 5. No clear history of abdominal surgery 6. The patient's family members had good communication skills and were able to complete the records and follow-up according to the requirements of the study protocol. The patient's family members signed informed consent and were willing to participate in the clinical trial

Exclusion criteria

Exclusion criteria: 1. People who are allergic to or have adverse reactions to the same drugs 2. Patients with intestinal obstruction 3. Patients with irritable bowel syndrome 4. There are serious metabolic diseases, serious chronic cardiovascular and cerebrovascular diseases, lung, liver, kidney and other chronic diseases, combined with disease medication may affect gastrointestinal motility and constipation symptoms (such as morphine, spasmolytics, calcium antagonists, etc.) 5. A history of alcohol, poison and/or drug abuse 6. Obvious psycho-psychological disorder Seven. People who have participated in clinical trials of other investigational drugs in the past 12 weeks 8. Constipation due to other diseases, functional defecation disorders and drugs, such as: prorectal swelling, pelvic floor Spasm, megacolon, etc 9. Chronic laxative abusers

Design outcomes

Primary

MeasureTime frame
marked effective rate;effective rate;

Secondary

MeasureTime frame
Time of onset;Apparent time;Improvement of intestinal flora before treatment and at 28 days;

Countries

Chna

Contacts

Public ContactTing Zhang

Children’s hospital of Shanghai Jiao Tong University School of Medicine

zhangt@shchildren.com.cn+86 180 1648 7615

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026