Current partner codePEPTIDESDE
NCT04532879·Not applicable·INTERVENTIONAL

HygiRelief Procedure and HygiSample Evaluation for Functional Constipation

Status

Withdrawn

Phase

Not applicable

Enrollment

0

Locations

0

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

This study has a single center, prospective, open label design. The population will include patients diagnosed with Rome IV Functional Constipation who are at the time of study enrollment being managed with a stable dose of Linzess. They will stop taking their Linzess, undergo monitoring of bowel habits for 2 weeks, have a HygiRelief procedure and then undergo an additional 2 weeks of bowel habit monitoring.

Full detailed description

After undergoing a 5-7 day Linzess washout period, patients will record their bowel habits in a daily diary for 2 weeks. Patients will have the HygiRelief procedure with a HygiSample evaluation, then they will record their bowel habits in a daily diary for 2 weeks following the HygiRelief procedure. HygiSamples (stool samples) will be collected throughout the HygiRelief procedure and the samples will be sent for microbiome evaluation. Patients will complete multiple questionnaires - Happiness Scale, Hospital Anxiety and Depression Scale (HADS), and a personal assessment which includes the Constipation Symptom Score and Adverse Event Screening. These will be completed at Baseline, after the 2 week PRE-HygiRelief period, and after the 2 week POST-HygiRelief period.

Interventions

Treatment arms and agents.

DEVICE

HygiPrep (HyGIeaCare System)

Controlled gravity-based high-volume colon irrigation

Timeline

From registration to results.

  1. First posted

    Aug 31, 2020

  2. Study start

    Sep 2021

  3. Primary completion

    Mar 2022

  4. Study completion

    Jun 2022

  5. Results posted

    Not reported

  6. Registry updated

    Sep 17, 2021

Outcomes

What the study measures.

Primary outcomes

Assess change in bowel movements PRE and POST HygiRelief procedure

Time frame · 12 months

Evaluate the clinical effectiveness of the HygiRelief procedure to relieve functional constipation in patients previously managed with a stable dose of Lizess

Secondary outcomes

Assess colon effluent samples (HygiSample) collected during the HygiRelief procedure

Time frame · 12 months

Samples will be evaluated for their microbiological and biochemical content, as well as to identify microbiome changes throughout the colon

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
80 Years
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: 1. Patient's age is between 18 and 80 years old 2. Patient diagnosed with Rome IV Functional Constipation (Attachment C2) 3. Patient is currently managed with Linzess and willing to stop taking it for study duration Exclusion Criteria: 1. Patient has functional bowel disorders characterized by alternating bowel habits (diarrhea/constipation) 2. Patient has any other condition that, in the opinion of the investigator, may adversely affect the compliance or safety of the patient or would limit the patient's ability to complete the study 3. Patient has any of the contraindications listed below: 1. Cardiac: Congestive heart failure (NYHA class III or IV or EF \<50%) 2. GI: Intestinal perforation, carcinoma of the rectum, fissures or fistula, severe hemorrhoids, abdominal hernia, recent colon, rectal, or abdominal surgery 3. GU: Renal insufficiency (CC \< 60 ml/min/173m2), cirrhosis with ascites 4. Abdominal surgery within the last 6 months 5. Pregnancy 4. Patient took antibiotics within two months of starting the study

Study locations

0 registered sites.

No country data reported. Showing up to 24 locations stored in the fast local snapshot.

No study locations reported.

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

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Put the record in context.

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