Diet and Fecal Incontinence in Senior Women
Status: | Recruiting |
---|---|
Conditions: | Gastrointestinal |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 65 - Any |
Updated: | 9/8/2018 |
Start Date: | January 1, 2018 |
End Date: | January 1, 2019 |
Contact: | Uduak U Andy, MD |
Email: | UduakUmoh.Andy@uphs.upenn.edu |
Phone: | (215) 662-3957 |
Diet Modification Program for Senior Women With Fecal Incontinence
Investigators will conduct a single-arm pre-post intervention pilot study in 46 older women
with Fecal Incontinence (FI), also known as Accidental Bowel Leakage (ABL). FI symptoms and
stool metabolites will be measured at baseline. Intervention with the Diet Modification
Program (DMP) will be administered. FI symptoms and stool metabolites will be measured after
6weeks of the intervention.
with Fecal Incontinence (FI), also known as Accidental Bowel Leakage (ABL). FI symptoms and
stool metabolites will be measured at baseline. Intervention with the Diet Modification
Program (DMP) will be administered. FI symptoms and stool metabolites will be measured after
6weeks of the intervention.
Study Procedure: Visit Schedule
Visit 1(Baseline visit): Following consent, the study coordinator will obtain participant's
demographic data including age, race/ethnicity, body mass index. Data on medical
comorbidities, surgical history and medications known to be associated with FI will be
collected. The participant's severity of FI will be measured using the St. Mark's Vaizey
scale (Vaizey). The impact of FI on quality of life will be measured using the Fecal
Incontinence Quality of Life scale (FIQL). The presence, type, and severity of other pelvic
floor symptoms known to be associated with FI will be assessed using the Pelvic floor
Distress Inventory- Short Form. Participants will be given a Food and Bowel Symptom diary and
a stool collection kit at the conclusion of the visit.
Visit 2(Intervention visit): Stool sample will be collected by the study coordinator.
Investigators will administer the DMP. Participants will be given the booklet outlining the
DMP and investigators will review the participant's Food and Symptom diary and provide
targeted recommendations. The participant will be given a second Food and Symptom diary and
stool collection kit to return 6 weeks after the intervention start date.
Calls: Trained Nutritionists will call the participant between weeks 2 and 4 for three
unannounced 24h diet recall. The 24-hour dietary recalls will be collected using Nutrition
Data System for Research, a computer-based software application that facilitates the
collection of recalls in a standardized fashion.
Visit 3 (Follow up visit): Post intervention stool samples and Food and Symptom diary will be
collected. Questionnaires including the Vaizey, FIQL, Pelvic Floow Disability Index (PFDI),
and Patient Global Index of Improvement (PGI-I) will be administered by the study
coordinator. Participants will receive compensation for participating in the study.
Visit 1(Baseline visit): Following consent, the study coordinator will obtain participant's
demographic data including age, race/ethnicity, body mass index. Data on medical
comorbidities, surgical history and medications known to be associated with FI will be
collected. The participant's severity of FI will be measured using the St. Mark's Vaizey
scale (Vaizey). The impact of FI on quality of life will be measured using the Fecal
Incontinence Quality of Life scale (FIQL). The presence, type, and severity of other pelvic
floor symptoms known to be associated with FI will be assessed using the Pelvic floor
Distress Inventory- Short Form. Participants will be given a Food and Bowel Symptom diary and
a stool collection kit at the conclusion of the visit.
Visit 2(Intervention visit): Stool sample will be collected by the study coordinator.
Investigators will administer the DMP. Participants will be given the booklet outlining the
DMP and investigators will review the participant's Food and Symptom diary and provide
targeted recommendations. The participant will be given a second Food and Symptom diary and
stool collection kit to return 6 weeks after the intervention start date.
Calls: Trained Nutritionists will call the participant between weeks 2 and 4 for three
unannounced 24h diet recall. The 24-hour dietary recalls will be collected using Nutrition
Data System for Research, a computer-based software application that facilitates the
collection of recalls in a standardized fashion.
Visit 3 (Follow up visit): Post intervention stool samples and Food and Symptom diary will be
collected. Questionnaires including the Vaizey, FIQL, Pelvic Floow Disability Index (PFDI),
and Patient Global Index of Improvement (PGI-I) will be administered by the study
coordinator. Participants will receive compensation for participating in the study.
Inclusion Criteria:
1. Age ≥ 65 years,
2. FI defined as any uncontrolled loss of liquid or solid fecal material that occurs at
least monthly over the last 3 months that is bothersome enough to desire treatment,
3. adequate mobility for independent toileting,
4. ability for independent completion of food symptom diary,
5. has some control of her diet and is able to make adjustments
6. able to read and communicate in English,
7. willing to give informed consent
Exclusion Criteria:
1. Currently receiving another treatment for FI
2. significant cognitive impairment at baseline
3. residence in a care facility that provides meals (participants who are not able to
adjust their diet will be excluded because the intervention focuses on the
participant, not their care facility)
4. current bloody diarrhea,
5. current or past diagnosis of colorectal
We found this trial at
1
site
3400 Spruce St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
(215) 662-4000
Principal Investigator: Uduak Andy, MD
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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