Clinical trial NCT06963125: The Effects of Prune Juice on Bowel Movement Patterns, Constipation Symptoms, and Quality of Life
Official 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Constipation in Older Adults
Functional Constipation in Elderly
Lead sponsor: Dalin Tzu Chi General Hospital
Sponsor class: OTHER
First posted: 2025-05-08
Enrollment: 90
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in Stool Consistency Measured by Bristol Stool Form Scale (BSFS)
timeFrame: From study enrollment to the end of the 4-week intervention
measure: Change in Constipation Symptoms Measured by PAC-SYM
timeFrame: From study enrollment to the end of the 4-week intervention
Secondary outcomes:
Other outcomes:
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