Constipation in Older AdultsNCT06963125
The Effects of Prune Juice on Bowel Movement Patterns, Constipation Symptoms, and Quality of Life
A study testing Low-Dose Prune Juice, Medium-Dose Prune Juice and High-Dose Prune Juice in people with Constipation in Older Adults and Functional Constipation in Elderly, run by Dalin Tzu Chi General Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Constipation in Older Adults, Functional Constipation in Elderly
- What is being tested?
- Low-Dose Prune Juice, Medium-Dose Prune Juice and High-Dose Prune Juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 May 2025to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Older adults aged 65 to 100 years
- Cognitively aware and able to express their opinions
- Diagnosed with functional constipation
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Licensed Long-Term Care Institutions in Chiayi Region
Chiayi City, Chiayi County, 51591
Li-Zhen Lin, 05-264-8000, lin.lone1118@gmail.com
About this study
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
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.
Read the 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).
- Being tested
- Low-Dose Prune Juice, Medium-Dose Prune Juice, High-Dose Prune Juice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Dose Prune JuiceDietary supplement
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.
Medium-Dose Prune JuiceDietary supplement
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.
High-Dose Prune JuiceDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group 1 | Experimental | 30 elderly individuals residing in long-term care facilities, aged between 65 and 100 years, who have been diagnosed with functional constipation. Receives: Dietary Supplement: Low-Dose Prune Juice |
| Experimental Group 2 | Experimental | 30 elderly individuals residing in long-term care facilities, aged between 65 and 100 years, who have been diagnosed with functional constipation. Receives: Dietary Supplement: Medium-Dose Prune Juice |
| Experimental Group 3 | Experimental | 30 elderly individuals residing in long-term care facilities, aged between 65 and 100 years, who have been diagnosed with functional constipation. Receives: Dietary Supplement: High-Dose Prune Juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From study enrollment to the end of the 4-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start26 May 2025
- Primary completion20 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Constipation in Older AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dalin Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06963125
- Sponsor's protocol ID
- B11304037
- Status last verified
- May 2025
- First submitted
- 18 Mar 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to privacy concerns and the absence of a data-sharing infrastructure at this time.
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06963125
- Acronym / sponsor ID
- B11304037
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Dalin Tzu Chi General HospitalUniversity, hospital or other
- Study start
- 26 May 2025 (actual)
- Primary completion
- 20 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 8 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental Group 1 | Experimental | Dietary Supplement: Low-Dose Prune Juice30 elderly individuals residing in long-term care facilities, aged between 65 and 100 years, who have been diagnosed with functional constipation. |
| Experimental Group 2 | Experimental | Dietary Supplement: Medium-Dose Prune Juice30 elderly individuals residing in long-term care facilities, aged between 65 and 100 years, who have been diagnosed with functional constipation. |
| Experimental Group 3 | Experimental | Dietary Supplement: High-Dose Prune Juice30 elderly individuals residing in long-term care facilities, aged between 65 and 100 years, who have been diagnosed with functional constipation. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Older adults aged 65 to 100 years
- Cognitively aware and able to express their opinions
- Diagnosed with functional constipation
Key exclusion criteria (19 listed)
- Diagnosis of diabetes mellitus
- Cognitive impairment, including moderate to severe dementia or psychiatric disorders
- Aphasia
- Severe hearing impairment
- Presence of gastrointestinal diseases, including:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-Dose Prune JuiceIntervention Name: Prune Juice 100 mL/day Description: 100 mL prune juice daily (1.07 g dietary fiber), administered once each morning for 4 weeks. | Dietary supplement | Experimental Group 1 |
| Medium-Dose Prune JuiceIntervention Name: Prune Juice 150 mL/day Description: 150 mL prune juice daily (1.61 g dietary fiber), administered once each morning for 4 weeks. | Dietary supplement | Experimental Group 2 |
| High-Dose Prune JuiceIntervention Name: Prune Juice 200 mL/day Description: 200 mL prune juice daily (3.22 g dietary fiber), administered once each morning for 4 weeks. | Dietary supplement | Experimental Group 3 |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to privacy concerns and the absence of a data-sharing infrastructure at this time.
Related trials for Constipation in Older Adults
Active, not recruitingObservational study
Functional Constipation and Fall-Related Outcomes in Older Adults
Functional Constipation (FC), Accidental Falls
Recruiting
BioAmicus Complete for Functional Gastrointestinal Symptoms in Infants Aged 0 to 24 Months
Infantile Colic, Gastroesophageal Reflux (GER)
Not yet recruitingObservational study
Prevalence of Functional Lower Urinary Tract Voiding Dysfunction in School-Aged Children
Voiding Dysfunction, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Licensed Long-Term Care Institutions in Chiayi Region
Chiayi City, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Dose Prune Juice, Medium-Dose Prune Juice and High-Dose Prune Juice in people with Constipation in Older Adults and Functional Constipation in Elderly, run by Dalin Tzu Chi General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Stool Consistency Measured by Bristol Stool Form Scale (BSFS) (time frame: From study enrollment to the end of the 4-week intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.