An interventional study of Low-Dose Prune Juice and Medium-Dose Prune Juice in Constipation in Older Adults and Functional Constipation in Elderly, sponsored by Dalin Tzu Chi General Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 65 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-09-12.
Sponsored by Dalin Tzu Chi General Hospital · Not applicable, Interventional, and Supportive care
This study investigates the effects of different prune juice dosages on bowel movement patterns, constipation symptoms, and quality of life in older adults. Using a factorial experimental design, 90 participants aged 65 to 100 with functional constipation will be randomly assigned to receive 100 mL, 150 mL, or 200 mL of prune juice daily for four weeks. The study aims to determine a safe and effective dosage for constipation management, offering a non-pharmacological approach to improving bowel health in older adults.
Constipation is a prevalent issue among older adults, leading to physical discomfort and long-term health complications. Non-pharmacological interventions are essential for effective management. This study aims to compare the effects of different prune juice dosages on bowel movement patterns, constipation symptoms, and quality of life to determine a safe and effective dosage for older adults. A factorial experimental design will be employed, with 90 participants aged 65 to 100 who are conscious, able to express their opinions, and diagnosed with functional constipation. Participants will be randomly assigned to three groups receiving 100 mL, 150 mL, or 200 mL of prune juice daily for four weeks. The outcomes will be assessed at five time points: before the intervention (T0), after one week (T1), after two weeks (T2), after three weeks (T3), and after four weeks (T4).
1,046 studies on the registry are indexed under Constipation; 161 are open to participants now.
This study's planned enrollment of 90 is above the median of 75 across 884 interventional studies indexed under Constipation.
Browse Constipation studies →Dalin Tzu Chi General Hospital is the lead sponsor of 37 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
30 elderly individuals residing in long-term care facilities, aged between 65 and 100 years, who have been diagnosed with functional constipation.
Dietary Supplement: Low-Dose Prune Juice
30 elderly individuals residing in long-term care facilities, aged between 65 and 100 years, who have been diagnosed with functional constipation.
Dietary Supplement: Medium-Dose Prune Juice
30 elderly individuals residing in long-term care facilities, aged between 65 and 100 years, who have been diagnosed with functional constipation.
Dietary Supplement: High-Dose Prune Juice
Intervention Name: Prune Juice 100 mL/day Description: 100 mL prune juice daily (1.07 g dietary fiber), administered once each morning for 4 weeks.
Intervention Name: Prune Juice 150 mL/day Description: 150 mL prune juice daily (1.61 g dietary fiber), administered once each morning for 4 weeks.
Intervention Name: Prune Juice 200 mL/day Description: 200 mL prune juice daily (3.22 g dietary fiber), administered once each morning for 4 weeks.
Change in Stool Consistency Measured by Bristol Stool Form Scale (BSFS)
Stool consistency will be assessed using the Bristol Stool Form Scale (BSFS), a 7-point scale that classifies stool into 7 types: Type 1 = separate hard lumps Type 7 = entirely liquid Types 3 to 5 are considered normal. The mean change in BSFS score from baseline to Week 4 will be measured. Higher or lower scores reflect changes in stool consistency severity.
Time frame: From study enrollment to the end of the 4-week intervention
Change in Constipation Symptoms Measured by PAC-SYM
Constipation symptoms will be assessed using the Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire. This instrument includes 12 items across abdominal, stool, and rectal symptom subscales. Each item is rated from 0 (no symptoms) to 4 (very severe). The total score ranges from 0 to 48, with higher scores indicating worse symptoms. The change in total PAC-SYM score from baseline to Week 4 will be evaluated.
Time frame: From study enrollment to the end of the 4-week intervention
Plan to share: No — Individual participant data (IPD) will not be shared due to privacy concerns and the absence of a data-sharing infrastructure at this time.
No publications or documents are linked to this record.
Started May 2025 (actual). Primary completion is estimated for Nov 2026, 17 months after the start.
Of 243 non-industry interventional studies with no phase under Constipation, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 35. This study's planned 17 months is close to that.
Counting every sponsor, half of 314 studies reached it within 14 months; a quarter within 6 and three quarters within 30.
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Dalin Tzu Chi General Hospital