Use of Ultrase® MT12 in Young Cystic Fibrosis Children (CF)

Exclusion Criteria

• •Patients currently receiving or received an Ultrase® MT product (MT12, MT18, MT20) for PI in the last 30 days
• •Patients having known contraindication, sensitivity or hypersensitivity to Ultrase® or to any porcine protein
• •Patients with presence of a medical condition known to increase fecal fat loss or that could compromise study results or the study patient safety
• •Patients with current diagnosis or history of complete distal intestinal obstruction syndrome (DIOS) in the past 6 months or who had 2 or more episodes of incomplete DIOS in the past year
• •Patients with use of any prohibited medication or product at study entry and during the course of the study
• •Patients with chronic use of narcotics
• •Patients with use of bowel stimulants and/or laxatives more than once a week
• •Patients with presence of acute pancreatitis or exacerbation of chronic pancreatic disease
• •Patients with presence of an acute infection that needed to be treated with oral or intravenous (IV) broad-spectrum antibiotics
• •Patients having history of significant bowel resection; small bowel resection for meconium ileus at birth and appendectomy were accepted. Patients with Presence of dysmotility disorders
• •Patients with presence of chronic or severe abdominal pain
• •Patients unable to comply with diet requirement
• •Patients receiving enteral tube feeding overnight at study entry or who will need to receive enteral tube feeding overnight during the course of the study
• •Patients with history of or a current diagnosis of clinically significant portal hypertension
• •Patients with presence of poorly controlled diabetes according to the Investigator's clinical judgment
• •Patients having any condition or pre-study laboratory abnormality or history of any illness which, in the opinion of the Investigator, might have put the patient at risk, prevented the patient from completing the study, or otherwise affect the outcome of the study
• •Patient with use of any investigational drug within 30 days prior to the date of signature of the ICF