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Efficacy and safety evaluation of short-term high-volume water intake intervention for functional chronic constipation

Efficacy and safety evaluation of short-term high-volume water intake intervention for functional chronic constipation

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600116474
Enrollment
Unknown
Registered
2026-01-11
Start date
2025-07-05
Completion date
Unknown
Last updated
2026-01-27

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

Conditions

Chronic functional constipation

Interventions

Patients with chronic functional constipation:Ingesting approximately 1.2 liters of room-temperature purified water within 10-15 minutes on an empty stomach every morning for four consecutive weeks

Sponsors

Zhongnan Hospital of Wuhan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Diagnosis consistent with Rome IV criteria for chronic constipation, with the presence of at least two or more of the following seven symptoms: •Sensation of anorectal obstruction or blockage during defecation in =25% of bowel movements; •Straining during defecation in =25% of bowel movements; •Lumpy or hard stools in =25% of bowel movements; •Sensation of incomplete evacuation in =25% of bowel movements; •Manual maneuvers required to facilitate defecation (e.g., digital evacuation or pelvic floor support) in =25% of bowel movements; •Fewer than three spontaneous bowel movements (SBMs) per week; •Rare occurrence of loose stools without the use of laxatives. 2.Age between 18 and 70 years. 3.No prior systematic treatment for constipation.

Exclusion criteria

Exclusion criteria: 1.Severe underlying diseases, including: •Decompensated heart failure (New York Heart Association [NYHA] class III-IV); •Uncontrolled hypertension (systolic blood pressure >160 mmHg or diastolic pressure >100 mmHg); •Acute coronary syndrome or stroke within the past 6 months. 2.Endocrine or metabolic disorders, including: •Diabetic nephropathy (estimated glomerular filtration rate [eGFR] 3 months) abuse of stimulant laxatives (e.g., senna, bisacodyl). 5.History of special treatments, including: •Gastrointestinal surgery or endoscopic interventions (e.g., intestinal stent placement) within the past 3 months; •Open abdominal surgery (e.g., cholecystectomy, hysterectomy) within the past 6 months; •Presence of abdominal drainage tubes or intestinal stoma. 6.Special physiological conditions: •Pregnancy or lactation (positive blood or urine hCG test). 7.Neuropsychiatric disorders: •Severe cognitive impairment (Mini-Mental State Examination [MMSE] score <24); •Neurodegenerative diseases such as Parkinson’s disease or multiple sclerosis.

Design outcomes

Primary

MeasureTime frame
complete spontaneous bowel movements;Cleveland Clinic Constipation Score;Bristol Stool Scale;Therapeutic Efficacy Index;

Secondary

MeasureTime frame
Score of Quality of Life Scale for Patients with Constipation;Score of Constipation Symptom Inventory;

Countries

China

Contacts

Public ContactJing Liu

Zhongnan Hospital of Wuhan University

liujing_gi@whu.edu.cn+86 189 7162 2466

Outcome results

None listed

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