for people ages 6 months to 17 years (full criteria)
at Oakland, California and other locations
study started
completion around
Principal Investigator
by Namrata Patel-Sanchez, MD



This is a Phase 4, U.S. only, multi-center study using a 7-day therapeutic response dose (TRD) of commercial Sucraid® to assess the response of treatment in 1100 symptomatic pediatric (6 months to 17 years old) subjects with low, moderate, and normal sucrase activity determined by a disaccharidase assay via EGD within 1 year of the Screening Visit. This study will also explore the relationship between known genetic CSID mutations and sucrase activities via (EGD) disaccharidase assay (low, moderate, and normal).

Official Title

Evaluation of a 7-Day Therapeutic Trial Dose of Commercial Sucraid® (Sacrosidase) Oral Solution for Alleviating Congenital Sucrase-Isomaltase Deficiency (CSID) Symptoms in Pediatric Subjects With Low, Moderate, and Normal Sucrase Levels


This phase 4 study will evaluate the response to Sucraid® in pediatric subjects aged 6 months to 17 years old with low (< 25 µM/min/gram protein), moderate (25-35 µM/min/gram protein), and normal (> 55 µM/min/gram protein) sucrase activities. Subjects with a sucrase level via disaccharidase assay from an EGD within 1 year of informed consent/assent, a normal histological interpretation, and at the discretion of the investigator, at least one symptom of carbohydrate maldigestion (CMS) of postprandial diarrhea, abdominal pain, gas/bloating, or defecation urgency at least 3 times per week for the past 3 months or more will be eligible for study participation. This study will also explore the relationship between three groups of sucrase levels from the EGD disaccharidase assay and the genetic test. This study will consist of a Screening Visit, Run-in Period, Baseline Visit, Treatment Period, and Follow-up Visit.


Congenital Sucrase-Isomaltase Deficiency, CSID, Sucrase Isomaltase Deficiency,, Inborn Errors Carbohydrate Metabolism, Sucraid (sacrosidase) Oral Solution 8500 IU/mL


You can join if…

Open to people ages 6 months to 17 years

  • Subjects with documented disaccharidase assay levels of lactase, sucrase, maltase, and palatinase via EGD disaccharidase assay (DA) performed no more than 1 year prior to enrollment with normal histological interpretation. Eligible subjects will be enrolled into the following study groups based on their documented sucrase level.
  • DA Sucrase < 25 (n=500)
  • DA Sucrase 25-35 (n=500)
  • DA Sucrase >55 (n=100)
  • At the discretion of the investigator, subject is suspected of CSID and has at least one symptom of diarrhea, abdominal pain, gas/bloating, nausea, or borborygmi at least 3x per week for the past 3 months or more.
  • Subject or parent/guardian must provide informed consent/assent prior to any study procedures being performed.
  • Subject is a U.S. resident.
  • Subject is male or female, ages 6 months to 17 years old.
  • Subject/parent or guardian is willing and able to complete necessary study procedures including following study instructions, completing electronic questionnaires via a personal mobile device, attending study visits and, in the Investigator's judgment, is sufficiently stable to participate in the study.
  • Subject/ parent or guardian must be able to read or understand the English language.
  • Subject or parent/guardian must have their own Android or Apple device for BYOD.

You CAN'T join if...

  • Females who are lactating or pregnant.
  • Subjects with allergy to sucrose, yeast, papain, or glycerol.
  • Subjects with causes of abdominal pain or altered bowel habits other than CSID such as inflammatory bowel disease, celiac disease, eosinophilic gastrointestinal disorder, pancreatitis, or gastrointestinal bleeding.
  • Subjects with a history of diabetes mellitus.
  • Subjects with a recent febrile illness (5 days prior to study).
  • Subjects that do not have the mental capacity to understand the study requirements and are unable to comply.
  • 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.
  • Subject has previously used Sucraid®.
  • Subject has uncontrolled systematic disease.


  • UCSF Benioff Children's Hospital Oakland accepting new patients
    Oakland California 94609 United States
  • Children's Hospital Los Angeles accepting new patients
    Los Angeles California 90027 United States

Lead Scientist at UCSF


accepting new patients
Start Date
Completion Date
QOL Medical, LLC
Phase 4 research study
Study Type
Expecting 1100 study participants
Last Updated