Licensed Long-Term Care Institutions in Chiayi Region
Chiayi City, Chiayi County, 51591, Taiwan
Location status: Recruiting
Recruiting
NCT Number: NCT06963125
The Effects of Prune Juice on Bowel Movement Patterns, Constipation Symptoms, and Quality of Life
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.
Recruiting
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Request InfoKey information
Age range
65 year–100 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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).
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Older adults aged 65 to 100 years
- Cognitively aware and able to express their opinions
- Diagnosed with functional constipation
Exclusion criteria
- Diagnosis of diabetes mellitus
- Cognitive impairment, including moderate to severe dementia or psychiatric disorders
- Aphasia
- Severe hearing impairment
- Presence of gastrointestinal diseases, including:
- Gastrointestinal bleeding
- Intestinal obstruction
- Abdominal tumors
- Irritable bowel syndrome
- Acute diverticulitis
- Diarrhea
- Crohn's disease
- Ulcerative colitis
- History of abdominal surgery
- Regular use of probiotics
- Regular use of traditional Chinese medicine or folk remedies for constipation relief
- Difficulty swallowing or risk of aspiration
- Major illnesses, such as current cancer treatment or severe cardiovascular diseases
- Currently hospitalized
Treatment and study plan
Low-Dose Prune Juice
Dietary SupplementIntervention Name: Prune Juice 100 mL/day Description: 100 mL prune juice daily (1.07 g dietary fiber), administered once each morning for 4 weeks.
Medium-Dose Prune Juice
Dietary SupplementIntervention Name: Prune Juice 150 mL/day Description: 150 mL prune juice daily (1.61 g dietary fiber), administered once each morning for 4 weeks.
High-Dose Prune Juice
Dietary SupplementIntervention Name: Prune Juice 200 mL/day Description: 200 mL prune juice daily (3.22 g dietary fiber), administered once each morning for 4 weeks.
Primary outcomes
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Change in Stool Consistency Measured by Bristol Stool Form Scale (BSFS)
Time frame: From study enrollment to the end of the 4-week intervention
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.
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Change in Constipation Symptoms Measured by PAC-SYM
Time frame: From study enrollment to the end of the 4-week intervention
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.
Sponsors and collaborators
Lead sponsor
Dalin Tzu Chi General Hospital
Other
Registry information
Official study title
The Effects of Different Doses of Prune Juice on Bowel Movement Patterns, Constipation Symptoms, and Quality of Life Among Older Adults in Long-Term Care Facilities
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- May 8, 2025
- Registry last updated
- Sep 12, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.