ConstipationPhase 4NCT01180725
Investigation of Dried Plums in the Treatment of Adults With Constipation
A Phase 4 study testing Dried Plum and Metamucil in people with Constipation, run by University of Iowa at 1 site in United States.
Trial summary
Background: Constipation is a common problem that affects nearly 60 million Americans. The treatment of constipation remains challenging with one half of patients dissatisfied with current therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Constipation
- What is being tested?
- Dried Plum and Metamucil
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- Adult, Older adult
Who may be able to join
- Constipation as defined by Rome III criteria (3,4). Patients must have symptoms for > 3 days/month for the past three months and report at least two of the following symptoms ≥ 25% of the time: straining, lumpy or hard stool, sensation of incomplete evacuation, sensation of anorectal obstruction/blockage, use of manual maneuvers, < 3 bowel movements/week. Also, they should have insufficient criteria for IBS, and only rarely experience loose stools without the use of laxatives
- Adults between the ages of 18-75 years
Who cannot join
- Patients taking drugs that are known to be constipating will be excluded or asked to discontinue medications for at least 2 weeks and reassessed. For example, we will recommend that patients taking calcium channel antagonists contact their respective primary care physicians to explore alternative medications for hypertension such as beta blockers or ACE-inhibitors. If the calcium channel antagonists can to be discontinued, patients will be re-screened at least two weeks after the medications are discontinued. If patients no longer meet inclusion criteria, they will be excluded from the study. Patients who remain constipated will be eligible for enrollment.
- Patients with co-morbid illnesses such as severe cardiovascular disease, chronic renal failure, or those with previous gastrointestinal surgery except cholecystectomy and appendectomy.
- Patients with neurologic diseases such as multiple sclerosis, strokes, spinal cord injuries, and those who have problems with cognizance, i.e. a mini-mental score of <15 and/or are legally blind will be excluded.
- Patients with Hirschsprung' s disease, or active local anorectal problems such as anal fissures, bleeding hemorrhoids, etc
- Patients with alternating constipation and diarrhea and those who fulfill the Rome-III criteria for irritable bowel syndrome.
- Patients using fiber supplements, laxatives, PEG, Tegaserod or Lubiprostone and unwilling to discontinue these medications at least 2 weeks prior to the study.
- Subjects with a known allergy to psyllium or plums.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
About this study
Background: Constipation is a common problem that affects nearly 60 million Americans. The treatment of constipation remains challenging with one half of patients dissatisfied with current therapy. There is a need for a food-based, natural, convenient and tasty alternative to the currently available OTC laxatives and fiber supplements, particularly for patients with occasional and mild constipation. Dried plums and prune juice have been traditionally used for the treatment of constipation but has not been systematically assessed in patients with well defined constipation. Also, the efficacy, palatability and tolerability of dried plums in the treatment of chronic constipation have not been examined.
Aim: To investigate and compare the effects of dried plums and psyllium on the overall relief of constipation symptoms, taste and quality of life in adults with functional constipation in a randomized crossover controlled trial.
Read more
Methods: We propose to study 40 subjects with functional constipation in a single blinded, randomized, cross-over study comparing 3 weeks of dried plums with 3 weeks of treatment with Psyllium
Data analysis: The primary outcome measure will be the global relief of constipation symptoms as rated by the subject at the end of each phase of the study. Additionally, we will assess several secondary outcome measures that will include the number of Complete Spontaneous Bowel Movements (CSBM) per week, Quality of Life , psychological profile, patient rating of taste on a VAS scale, patient rating of bloating, distension, satiety and fullness and patient rating of constipation-related symptoms.
Expected Results: We anticipate that treatment with dried plums will improve symptoms of constipation compared to the baseline. This improvement will be comparable to that achieved with psyllium (Metamucil) treatment. Additionally, dried plums will offer a natural, food based, convenient and more tasty alternative to over-the-counter laxatives and fiber supplements.
- Conditions
- Constipation
- Being tested
- Dried Plum, Metamucil
- Keywords
- To investigate and compare the effects of dried plums and psyllium on the overall relief of constipation symptoms, To investigate and compare the taste of dried plums and psyllium, To investigate and compare the quality of life of dried plums and psyllium
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dried PlumDietary supplement
MetamucilDietary supplement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- 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 4
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- California Dried Plum Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01180725
- Sponsor's protocol ID
- Dried Plum
- Status last verified
- Aug 2010
- First submitted
- 11 Aug 2010
- Last updated
- 12 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Dried Plums in the Treatment of Adults With Constipation
- ClinicalTrials.gov ID
- NCT01180725
- Acronym / sponsor ID
- Dried Plum
- Conditions
- Constipation
- Keywords
- To investigate and compare the effects of dried plums and psyllium on the overall relief of constipation symptoms, To investigate and compare the taste of dried plums and psyllium, To investigate and compare the quality of life of dried plums and psyllium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- California Dried Plum Board
- First posted
- 12 Aug 2010 (estimated)
- 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.
Background: Constipation is a common problem that affects nearly 60 million Americans. The treatment of constipation remains challenging with one half of patients dissatisfied with current therapy. There is a need for a food-based, natural, convenient and tasty alternative to the currently available OTC laxatives and fiber supplements, particularly for patients with occasional and mild constipation. Dried plums and prune juice have been traditionally used for the treatment of constipation but has not been systematically assessed in patients with well defined constipation. Also, the efficacy, palatability and tolerability of dried plums in the treatment of chronic constipation have not been examined.
Aim: To investigate and compare the effects of dried plums and psyllium on the overall relief of constipation symptoms, taste and quality of life in adults with functional constipation in a randomized crossover controlled trial.
Methods: We propose to study 40 subjects with functional constipation in a single blinded, randomized, cross-over study comparing 3 weeks of dried plums with 3 weeks of treatment with Psyllium
Data analysis: The primary outcome measure will be the global relief of constipation symptoms as rated by the subject at the end of each phase of the study. Additionally, we will assess several secondary outcome measures that will include the number of Complete Spontaneous Bowel Movements (CSBM) per week, Quality of Life , psychological profile, patient rating of taste on a VAS scale, patient rating of bloating, distension, satiety and fullness and patient rating of constipation-related symptoms.
Expected Results: We anticipate that treatment with dried plums will improve symptoms of constipation compared to the baseline. This improvement will be comparable to that achieved with psyllium (Metamucil) treatment. Additionally, dried plums will offer a natural, food based, convenient and more tasty alternative to over-the-counter laxatives and fiber supplements.
Study design
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Constipation as defined by Rome III criteria (3,4). Patients must have symptoms for > 3 days/month for the past three months and report at least two of the following symptoms ≥ 25% of the time: straining, lumpy or hard stool, sensation of incomplete evacuation, sensation of anorectal obstruction/blockage, use of manual maneuvers, < 3 bowel movements/week. Also, they should have insufficient criteria for IBS, and only rarely experience loose stools without the use of laxatives
- Adults between the ages of 18-75 years
Key exclusion criteria (7 listed)
- Patients taking drugs that are known to be constipating will be excluded or asked to discontinue medications for at least 2 weeks and reassessed. For example, we will recommend that patients taking calcium channel antagonists contact their respective primary care physicians to explore alternative medications for hypertension such as beta blockers or ACE-inhibitors. If the calcium channel antagonists can to be discontinued, patients will be re-screened at least two weeks after the medications are discontinued. If patients no longer meet inclusion criteria, they will be excluded from the study. Patients who remain constipated will be eligible for enrollment.
- Patients with co-morbid illnesses such as severe cardiovascular disease, chronic renal failure, or those with previous gastrointestinal surgery except cholecystectomy and appendectomy.
- Patients with neurologic diseases such as multiple sclerosis, strokes, spinal cord injuries, and those who have problems with cognizance, i.e. a mini-mental score of <15 and/or are legally blind will be excluded.
- Patients with Hirschsprung' s disease, or active local anorectal problems such as anal fissures, bleeding hemorrhoids, etc
- Patients with alternating constipation and diarrhea and those who fulfill the Rome-III criteria for irritable bowel syndrome.
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 |
|---|---|---|
| Dried Plum | Dietary supplement | – |
| Metamucil | Dietary supplement | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2010.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dried Plum and Metamucil in people with Constipation, run by University of Iowa at 1 site in United States.
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 2 inclusion and 7 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: finished, as of the sponsor's last update on 12 Aug 2010. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 Aug 2010.