Casein Glycomacropeptide in Active Distal Ulcerative Coli... | NCT01534312

Studies
Casein Glycomacropeptide in Active Distal Ulcerative Colitis (Pilot Study)

NCT01534312

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Nov 22, 2016Estimated

Enrollment

24Actual

Phase

Not Applicable

Conditions

Colitis, Ulcerative
Inflammatory Bowel Diseases

Interventions

CGMP protein
Maximal oral 5ASA

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Sep 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Feb 13, 2012

First Submission Date that Met QC Criteria

Feb 13, 2012

First Posted Date

Feb 16, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 20, 2016

Last Update Posted Date

Nov 22, 2016Estimated

Name	Class
Arla Foods	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Casein glycomacropeptide (CGMP) has anti-inflammatory properties in experimental rodent colitis and using human in vitro inflammation models. Its use as a food ingredient has proven safe and with no influence on dietary intake. We hypothesize that orally administered CGMP has a beneficial effect comparable to that of mesalazine in active distal ulcerative colitis.

Detailed Description

GCMP has mainly been used as food additive in patients with specific dietary needs, i.e. in infant formulas, adipositas, or in patient with phenylketonuria. Due to its antiinflammatory properties we hypothesize that it may be used alone or along with conventional therapy in inflammatory diseases such as ulcerative colitis.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CGMP protein	Experimental	Casein glycomacropeptide 30 gram/day, unchanged prophylactic 5ASA dose	Drug: CGMP protein
Standard oral 5ASA maximal dose	Active Comparator	Increase from prophylactic dose 5ASA (mesalazine) to maximal oral dose, i.e. 4800 grams of mesalazine (Asacol/Mezavant)	Drug: Maximal oral 5ASA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CGMP protein	Drug	Casein glycomacropeptide purified powder dissolved in 300 ML water once daily	CGMP protein

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fecal calprotectin reduction	Relative reduction in fecal calprotectin measured before and after 4 weeks	4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Clinical activity index	Simple Clinical Colitis Index, range 0-20	4 weeks
Quality of life	Quality of life measured yb Short Health Scale (4 items ranged 0-10, total range 0-40)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 years or more
Diagnosed ulcerative colitis
Signs of clinical activity with SCCAI of 3 or more
Extension more than 10 cm and no more than 40 cm from anus

Exclusion Criteria:

Rectal temperature more than 38 degrees Celcius
Diagnosed celiac disease or lactose intolerance
Unable to speak or understand Danish
Prior biologics or systemic steroids 4 weeks up to inclusion

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hendrik Vilstrup, Professor	Professor, University of Aarhus	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of medicine V (Hepatology and Gastroenterology)		Aarhus C	Aarhus C	8000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D003093	Colitis, Ulcerative
D015212	Inflammatory Bowel Diseases

Ancestor Terms

ID	Term
D003092	Colitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019804	Mesalamine

Ancestor Terms

ID	Term
D062368	meta-Aminobenzoates
D062365	Aminobenzoates
D001565	Benzoates
D000146	Acids, Carbocyclic

Browse Leaves

Not provided

Browse Branches

Not provided