A Trial to Evaluate the Frequency of Genetic Sucrase-Isomaltase Deficiency Genotypes, and the Efficacy and Safety of Sucraid® (Sacrosidase) Oral Solution in Subjects With Chronic Diarrhea and Sucrase Deficiency (GSID-E)

September 20, 2017 updated by: QOL Medical, LLC

A Multicenter, Double-Blind, Placebo-Controlled Trial to Evaluate the Frequency of Genetic Sucrase-Isomaltase Deficiency Genotypes, and the Efficacy and Safety of Sucraid® (Sacrosidase) Oral Solution in Subjects With Chronic Diarrhea and Sucrase Deficiency

S09A is a Phase 4, multicenter, randomized, double-blind, placebo-controlled, parallel study examining the efficacy and safety of a Sucraid (sacrosidase) Oral Solution in comparison to a placebo in 150-200 subjects with chronic diarrhea possibly attributable to sucrase deficiency.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject is 16 years of age or older.
  2. Subject is male or female. Women of childbearing potential must be willing to use one of the following contraception methods (for at least 10 days prior to start of study drug and for 10 to 14 days after last dose of study drug): Oral contraceptive, Injectable progestogen, Implants of levonorgestrel, Estrogenic vaginal ring, Percutaneous contraceptive patches, Intrauterine device, Sterile male partner, Double-barrier method of contraception Women of non-child bearing potential include females regardless of age with functioning ovaries and who have a current tubal ligation (Hatcher, 2004), bilateral oophorectomy, or total hysterectomy, or post-menopausal females. Note: Post-menopausal is defined as 1 year without menses with an appropriate clinical profile (e.g., age appropriate, >45 years, in the absence of hormone replacement therapy).
  3. Subject has a minimum of 3 months of self-reported diarrhea (BSFS scores ≥ 5 on at least 3 days per week and ≥1 stool per day)
  4. Subject has a value in the SHMBT of at least 20 ppm for hydrogen, or 12 ppm for methane or 15 ppm above a previous breath sample for the combination of both gases.
  5. Subject reports that he/she experienced soft stools or diarrhea within the last 24 hours when contacted by the site 24 hours after completing the SHMBT.
  6. Subject is able to read, speak, and verbally understand the English language.
  7. Subject is located in the United States.
  8. Subject has access to the Internet on a daily basis.
  9. Subject has access to an acceptable Apple iPhone/iPad/iTouch or Android smartphone/tablet. The sponsor may choose to provide a smartphone in unusual cases (please contact sponsor to request loaner device when applicable)

Exclusion Criteria:

  1. Subject has recent history of functional or chronic constipation.
  2. Subject has known history of ulcerative colitis, Crohn's disease, or Celiac disease.
  3. Subject has known hypersensitivity to papain, glycerol, or yeast.
  4. Subject has received bovine serum in the last year.
  5. Subject has previous history of Sucraid use.
  6. Subject has taken any prebiotic or probiotic within 5 days prior to Visit 2 and does not agree to refrain from taking them during the study.
  7. Subject is female and is pregnant, breastfeeding, or planning to become pregnant during the study.
  8. Subject has known uncontrolled systemic disease.
  9. Subject has prior diagnosis of Type 1 or Type 2 diabetes.
  10. Subject has history of bowel resection.
  11. Subject is undergoing chemotherapy for the treatment of cancer.
  12. Subject has major physical or psychiatric illness within the last 6 months that in the opinion of the investigator would affect the subject's ability to complete the trial.
  13. Subject has used an investigational device or investigational drug within 30 days prior to Visit 1.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Subjects randomized to the active treatment arm will take Sucraid, 2 mL (17,000 IU) with every meal or snack, administered orally following dilution with 2 to 4 ounces (60 to 120 mL) of water or milk (either cold or at room temperature). The study treatment period is one week.
Drug: Sucraid
Study drug
Other Names:
  • Sacrosidase
Placebo Comparator: Placebo
Subjects randomized to the placebo treatment arm will take Sucraid placebo, 2 mL (17,000 IU) with every meal or snack, administered orally following dilution with 2 to 4 ounces (60 to 120 mL) of water or milk (either cold or at room temperature). The study treatment period is one week.
Drug: Placebo
Sucraid placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response to Sucraid and placebo in a parallel group study based on improvement in daily stool consistency, as assessed by the BSFS using SHMBT
Time Frame: Up to 2 years
Response to Sucraid and placebo based on improvement in daily stool consistency, as assessed by the Bristol Stool Form Scale (BSFS) over a 1-week treatment period in subjects with chronic diarrhea and sucrase deficiency using a sucrose hydrogen methane breath test (SHMBT).
Up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects of Sucraid and placebo on daily assessments of Bristol Stool Form Scale
Time Frame: Up to 2 years
Up to 2 years
Effects of Sucraid and placebo on daily stool frequency
Time Frame: Up to 2 years
Up to 2 years
Effects of Sucraid and placebo on daily abdominal pain
Time Frame: Up to 2 years
Up to 2 years
Effects of Sucraid and placebo on daily bloating severity
Time Frame: Up to 2 years
Up to 2 years
The relationship between the severity of sucrase deficiency, quantified by a SHMBT
Time Frame: Up to 2 years
Up to 2 years
The mean improvement in the BSFS for each treatment group.
Time Frame: Up to 2 years
Up to 2 years
Overall frequency of the 4 most common sucrase-isomaltase deficiency genetic variants
Time Frame: Up to 2 years
Overall frequency of the 4 most common sucrase-isomaltase deficiency genetic variants in comparison to the frequency in public proxy databases of broad populations.
Up to 2 years
The number of less common sucrase-isomaltase polymorphisms in this study population.
Time Frame: Up to 2 years
Up to 2 years
The allele frequency of the most common sucrase-isomaltase genetic variants in subjects with chronic diarrhea attributable to sucrase deficiency compared to the allele frequency in other databases
Time Frame: Up to 2 years
Assess the allele frequency of the 38 most common sucrase-isomaltase genetic variants in subjects with chronic diarrhea attributable to sucrase deficiency compared to the allele frequency of sucrase-isomaltase genetic variants in the Exome Variant Server, the ExAC server, and other public proxy and private genetic databases.
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

QOL Medical, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

May 18, 2016

First Submitted That Met QC Criteria

May 23, 2016

First Posted (Estimate)

May 26, 2016

Study Record Updates

Last Update Posted (Actual)

September 25, 2017

Last Update Submitted That Met QC Criteria

September 20, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S09A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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