Psyllium for Fecal Soiling

Phase-Based Estimates
1
Effectiveness
1
Safety
Massachusetts General Hospital, Boston, MA
Fecal Soiling+4 More
Psyllium - DietarySupplement
Eligibility
18+
Female
Eligible conditions
Fecal Soiling

Study Summary

This study is evaluating whether fiber supplementation may help improve symptoms of irritable bowel syndrome.

See full description

Eligible Conditions

  • Fecal Soiling
  • Fecal Incontinence
  • Syndrome
  • Diarrhea
  • Irritable Bowel Syndrome
  • Diarrhoea Predominant Irritable Bowel Syndrome

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Psyllium will improve 2 primary outcomes and 9 secondary outcomes in patients with Fecal Soiling. Measurement will happen over the course of Change from baseline to final visit. Through study completion, up to 6 weeks..

Week 6
Anorectal manometry parameters
Bloating scale
Fecal Incontinence quality of life (FIQL)
Fecal incontinence severity index (FISI)
Flatus scale
Global assessment of relief
Stool metagenomics
Stool microbiome
Translumbosacral anorectal magnetic stimulation
Urgency scale
Waist circumference measurement (cm)

Trial Safety

Side Effects for

Part B: LIK066 + 50% CHO + PS
Diarrhea
71%
Constipation
8%
Flatulence
8%
Dyspepsia
8%
Vomiting
4%
Headache
4%
Nausea
4%
Abdominal pain
4%
Anorectal discomfort
0%
Dysuria
0%
Abdominal discomfort
0%
Abdominal distension
0%
Gastrointestinal pain
0%
Burning sensation
0%
Scab
0%
Abdominal pain lower
0%
Peripheral swelling
0%
Dizziness
0%
Back pain
0%
Erythema
0%
Pruritus
0%
Vessel puncture site pain
0%
Decreased appetite
0%
Scratch
0%
This histogram enumerates side effects from a completed 2017 Phase 2 trial (NCT03198767) in the Part B: LIK066 + 50% CHO + PS ARM group. Side effects include: Diarrhea with 71%, Constipation with 8%, Flatulence with 8%, Dyspepsia with 8%, Vomiting with 4%.

Trial Design

2 Treatment Groups

Control
Psyllium fiber supplement treatment

This trial requires 30 total participants across 2 different treatment groups

This trial involves 2 different treatments. Psyllium is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Psyllium fiber supplement treatment
DietarySupplement
All patients will receive psyllium fiber in the form of edible bars, 7g, twice a day to total 14g per day.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psyllium
2015
Completed Phase 4
~590

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change from baseline to final visit. through study completion, up to 6 weeks.
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly change from baseline to final visit. through study completion, up to 6 weeks. for reporting.

Who is running the study

Principal Investigator
K. S.
Prof. Kyle Staller,, MD
Massachusetts General Hospital

Closest Location

Massachusetts General Hospital - Boston, MA

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Female, post-menopausal
Age 55-85 years old
You have a body mass index (BMI) of at least 18.5 and less than 40 kg/m2. show original
At least one FI episode during the run-in period
Ability to follow verbal and written instructions
Informed consent form signed by the subjects
You have liquid stool fecal incontinence occurring at least twice per month. show original
You are compliant with reporting during run-in. show original
You have submitted two stool samples during the run-in period. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of fecal soiling?

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The presenting feature is constipation in children. Seemingly solid stools are a common feature but may also be present from the earliest phases of this disease. The use of defecating proctoscopy can be a powerful contribution. In children with no symptoms, an abnormal proctospy result can be an early indicator of this condition.

Unverified Answer

Can fecal soiling be cured?

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If a person is bothered by fecal soiling, it should be tried to be cured by diet. If this fails to improve or does not do any harm, the person needs further investigations. In most cases (especially those with chronic or severe fecal soiling) fecal microbiota transplantation can be successful once the intestinal flora has been wiped out. Surgical correction of the anal sphincters may be necessary to prevent fecal leakage.

Unverified Answer

What is fecal soiling?

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Fecal soiling is a symptom that may be present in an adult who is otherwise well. Fecal soiling is an indicator of underlying diseases which cause other symptoms and should be sought after whenever a patient with soiling is examined.

Unverified Answer

What are common treatments for fecal soiling?

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As with many chronic diseases, fecal soiling is commonly not adequately treated, despite this being the most common form of fecal incontinence that occurs in the general population. The most commonly used therapies for fecal soiling are stool softeners, laxatives, and bisacodyl. These agents may provide significant short and long term improvement of symptoms. More research is needed to explore the mechanisms of effectiveness.

Unverified Answer

How many people get fecal soiling a year in the United States?

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Most people who get fecal soiling a year may have only one episode per year. Only about 2% get 2 or more episodes a year. Fecal soiling has a significant impact on health and quality of life and should routinely be considered in the context of bowel health in adults.

Unverified Answer

What causes fecal soiling?

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Fecal soiling is associated with fecal contamination, particularly in elderly people. The incidence of soiling appears to be strongly related to housing. In a recent study, findings may explain the links between poor housing and the increased incidence of disease in older people.

Unverified Answer

What is the latest research for fecal soiling?

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[Fecal soiling has received many different treatments from dietary supplements to probiotic supplements, but so far there has been no proven benefit to soiling and fecal management.] The main goal of fecal management and management guidelines is to reduce fecal soiling, and treatment for soiling should be [considered] when warranted, and should follow the latest research. [Power] allows you to quickly obtain recent research and is a great tool for clinicians trying to manage fecal soiling and patients looking for a fast and reliable way to get their treatments in place. [Power] may also help you decide to seek out more research to help in overcoming fecal soiling, such as fecal microbiota manipulation.

Unverified Answer

What is the primary cause of fecal soiling?

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[Fecal soiling can be caused by an organic obstruction, or a mechanical obstruction such as colon obstruction, pelvic adhesions, diverticulosis, or a malignancy as in the presence of diarrhea. The diagnosis of fecal soiling should be made on examination of the stool only and should exclude organic or mechanical causes] (lupus.org/conditions-and-diseases/abdominal-symptoms/fecal-soiling.html). If no organic causes are suspected, a colonoscopic exam should be done to make sure there are no other causes like adenomatous polyps.

Unverified Answer

Has psyllium proven to be more effective than a placebo?

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The study results showed more participants in the placebo group were free from straining for 3 years than in the psyllium group. The statistical significance is at the 1-percent level.

Unverified Answer

What is the average age someone gets fecal soiling?

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Young people who have fecal soiling before the age of 16 are more likely to have it on a regular basis. Onset is earlier in those of female gender, and for those who have regular fecal soiling before the age of 16.

Unverified Answer

What are the common side effects of psyllium?

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Most gastro-intestinal adverse effects associated to psyllium intake were mild to moderate. No adverse effects were identified in the large majority of subjects from the main clinical trial. This lack of safety of psyllium in the long-term can be considered as a justification for taking a balanced view in the assessment of its safety and safety profile in this patient population.

Unverified Answer

What is psyllium?

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[Psyllium is a fibre supplement that promotes healthy intestinal activity, helps you to pass a normal bowel movement more easily through your daily activities, and helps you with constipation symptoms by adding bulk to your stool and making it harder for you to defecate] (https://www.mcgill.ca/info/cereals/cariagen.html). While you may be interested in learning more about the effects of psyllium on health, there are no controlled clinical studies that definitively link its use with any health-related effects. If you want to take psyllium as a supplement, check with your doctor to inform your doctor about all of your medication, supplements, and foods.

Unverified Answer
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