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Aquamin® as an Adjuvant Intervention for Ulcerative Colitis

Primary Purpose

Ulcerative Colitis

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Aquamin®

Placebo first then Aquamin®

About this trial

This is an interventional supportive care trial for Ulcerative Colitis focused on measuring Remission

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Ulcerative colitis with confirmed diagnosis by histology and endoscopy AND in stable remission for 3 months or more without therapy or with maintenance therapy (except steroids and antibiotics for 3 months) OR having a mild disease.
A negative pregnancy test

Exclusion Criteria:

No history or diagnosis of any of the following conditions: Crohn's disease, bleeding disorders, gastrointestinal or colonic malignancy, Kidney disease, including kidney "stones" or hypercalcemia, Coagulopathy/hereditary hemorrhagic disorders/ or receiving therapeutic doses of Coumadin or heparin.
Ingested certain medications (Calcium, Vitamin D, fiber supplements and Non-steroidal anti-inflammatory drugs - NSAIDs) within 30 days of study start.

Sites / Locations

The University of MichiganRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Aquamin®

Placebo first then Aquamin®

Arm Description

To be taken for 180 days

Placebo: To be taken for the first 90 days. Aquamin®: To be taken for the last 90 days (after crossover)

Outcomes

Primary Outcome Measures

Change in ulcerative colitis clinical features / presentation as measured by the Inflammatory Bowel Disease Questionnaire (IBDQ) score

This is a self-administered questionnaire. There are 32 quality of life questions related to bowel function. Each response corresponds to a letter 'a' through 'g'. Whereas 'a' indicates high frequency and 'g' indicates minimal frequency. The total IBDQ score ranges between 32 and 224, with higher scores indicating better quality of life.

Change in clinical assessment /gastroenterologist's endoscopic findings based on Ulcerative Colitis Disease Activity Index (UCDAI)/Mayo Scoring

UCDAI/Mayo Scoring consists of 4 subscales: stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscale is scored on a scale of 0 to 3, where 0= normal condition and 3 = severe disease condition. The total Mayo score ranges from 0 to 12, with higher scores indicating more severe disease.

Change in Cytokine levels of the colon tissue as measured by Interleukin 8 (IL-8) levels assessed by enzyme-linked immunosorbent assay (ELISA)

Interleukin 8 levels are measured in picograms per milliliter (pg/mL)

Change in serum C-reactive protein (CRP) levels as measured in a blood sample.

Serum C-reactive protein ([CRP levels)] will be reported in milligram per deciliter (mg/dL)

Change in fecal calprotectin levels measured in a stool sample

Fecal calprotectin will be reported in microgram per gram (µg/g)

Secondary Outcome Measures

Changes in serum liver function tests

Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), and Alkaline Phosphatase (ALKP) assessment

Full Information

NCT ID

NCT03869905

First Posted

March 8, 2019

Last Updated

April 1, 2023

Sponsor

James Varani

1. Study Identification

Unique Protocol Identification Number

NCT03869905

Brief Title

Aquamin® as an Adjuvant Intervention for Ulcerative Colitis

Official Title

Aquamin®, a Multi-mineral Natural Product From Red Marine Algae, as an Adjuvant Intervention for Mild Ulcerative Colitis and Ulcerative Colitis in Remission

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 8, 2019 (Actual)

Primary Completion Date

April 2024 (Anticipated)

Study Completion Date

June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

James Varani

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The purpose of this study is to determine if Aquamin® works as a potential treatment to improve symptoms and if it will induce remission in patients with mild Ulcerative Colitis and extend remission in Ulcerative Colitis in remission.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ulcerative Colitis

Keywords

Remission

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

This pilot study includes individuals with mild ulcerative colitis / ulcerative colitis in remission, and is a randomized, double-blind, placebo-controlled trial with two parallel treatment groups for the first 90 days. Subjects on placebo will be crossed over to Aquamin® after the halfway visit at day 90. Subjects on Aquamin® will continue their treatment until the end.

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Aquamin®

Arm Type

Experimental

Arm Description

To be taken for 180 days

Arm Title

Placebo first then Aquamin®

Arm Type

Placebo Comparator

Arm Description

Placebo: To be taken for the first 90 days. Aquamin®: To be taken for the last 90 days (after crossover)

Intervention Type

Drug

Intervention Name(s)

Aquamin®

Other Intervention Name(s)

Nutritional

Intervention Description

4 capsules per day; 2 to be taken in the morning and 2 in the evening (containing approximately 800 mg calcium/day)

Intervention Type

Drug

Intervention Name(s)

Placebo first then Aquamin®

Other Intervention Name(s)

Maltodextrin

Intervention Description

4 capsules per day; 2 to be taken in the morning and 2 in the evening

Primary Outcome Measure Information:

Title

Change in ulcerative colitis clinical features / presentation as measured by the Inflammatory Bowel Disease Questionnaire (IBDQ) score

Description

Time Frame

Up to day 180

Title

Change in clinical assessment /gastroenterologist's endoscopic findings based on Ulcerative Colitis Disease Activity Index (UCDAI)/Mayo Scoring

Description

Time Frame

Up to day 180

Title

Change in Cytokine levels of the colon tissue as measured by Interleukin 8 (IL-8) levels assessed by enzyme-linked immunosorbent assay (ELISA)

Description

Interleukin 8 levels are measured in picograms per milliliter (pg/mL)

Time Frame

Up to day 180

Title

Change in serum C-reactive protein (CRP) levels as measured in a blood sample.

Description

Serum C-reactive protein ([CRP levels)] will be reported in milligram per deciliter (mg/dL)

Time Frame

Up to day 180

Title

Change in fecal calprotectin levels measured in a stool sample

Description

Fecal calprotectin will be reported in microgram per gram (µg/g)

Time Frame

Up to day 180

Secondary Outcome Measure Information:

Title

Changes in serum liver function tests

Description

Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), and Alkaline Phosphatase (ALKP) assessment

Time Frame

Up to day 180

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Ulcerative colitis with confirmed diagnosis by histology and endoscopy AND in stable remission for 3 months or more without therapy or with maintenance therapy (except steroids and antibiotics for 3 months) OR having a mild disease. A negative pregnancy test Exclusion Criteria: No history or diagnosis of any of the following conditions: Crohn's disease, bleeding disorders, gastrointestinal or colonic malignancy, Kidney disease, including kidney "stones" or hypercalcemia, Coagulopathy/hereditary hemorrhagic disorders/ or receiving therapeutic doses of Coumadin or heparin. Ingested certain medications (Calcium, Vitamin D, fiber supplements and Non-steroidal anti-inflammatory drugs - NSAIDs) within 30 days of study start.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Muhammad Nadeem Aslam

Phone

734-936-1897

mnaslam@umich.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James Varani

Organizational Affiliation

University of Michigan

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Muhammad N Aslam

Organizational Affiliation

University of Michigan

Official's Role

Study Director

Facility Information:

Facility Name

The University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Muhammad N Aslam

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33330453

Citation

Aslam MN, McClintock SD, Attili D, Pandya S, Rehman H, Nadeem DM, Jawad-Makki MAH, Rizvi AH, Berner MM, Dame MK, Turgeon DK, Varani J. Ulcerative Colitis-Derived Colonoid Culture: A Multi-Mineral-Approach to Improve Barrier Protein Expression. Front Cell Dev Biol. 2020 Nov 23;8:577221. doi: 10.3389/fcell.2020.577221. eCollection 2020.

Results Reference

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PubMed Identifier

30995271

Citation

Attili D, McClintock SD, Rizvi AH, Pandya S, Rehman H, Nadeem DM, Richter A, Thomas D, Dame MK, Turgeon DK, Varani J, Aslam MN. Calcium-induced differentiation in normal human colonoid cultures: Cell-cell / cell-matrix adhesion, barrier formation and tissue integrity. PLoS One. 2019 Apr 17;14(4):e0215122. doi: 10.1371/journal.pone.0215122. eCollection 2019.

Results Reference

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PubMed Identifier

32134920

Citation

McClintock SD, Attili D, Dame MK, Richter A, Silvestri SS, Berner MM, Bohm MS, Karpoff K, McCarthy CL, Spence JR, Varani J, Aslam MN. Differentiation of human colon tissue in culture: Effects of calcium on trans-epithelial electrical resistance and tissue cohesive properties. PLoS One. 2020 Mar 5;15(3):e0222058. doi: 10.1371/journal.pone.0222058. eCollection 2020.

Results Reference

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PubMed Identifier

31771942

Citation

Aslam MN, Bassis CM, Bergin IL, Knuver K, Zick SM, Sen A, Turgeon DK, Varani J. A Calcium-Rich Multimineral Intervention to Modulate Colonic Microbial Communities and Metabolomic Profiles in Humans: Results from a 90-Day Trial. Cancer Prev Res (Phila). 2020 Jan;13(1):101-116. doi: 10.1158/1940-6207.CAPR-19-0325. Epub 2019 Nov 26.

Results Reference

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PubMed Identifier

33799486

Citation

Aslam MN, McClintock SD, Jawad-Makki MAH, Knuver K, Ahmad HM, Basrur V, Bergin IL, Zick SM, Sen A, Turgeon DK, Varani J. A Multi-Mineral Intervention to Modulate Colonic Mucosal Protein Profile: Results from a 90-Day Trial in Human Subjects. Nutrients. 2021 Mar 14;13(3):939. doi: 10.3390/nu13030939.

Results Reference

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PubMed Identifier

33403624

Citation

Varani J, McClintock SD, Aslam MN. Organoid culture to study epithelial cell differentiation and barrier formation in the colon: bridging the gap between monolayer cell culture and human subject research. In Vitro Cell Dev Biol Anim. 2021 Feb;57(2):174-190. doi: 10.1007/s11626-020-00534-6. Epub 2021 Jan 5.

Results Reference

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PubMed Identifier

35360746

Citation

Varani J, McClintock SD, Aslam MN. Cell-Matrix Interactions Contribute to Barrier Function in Human Colon Organoids. Front Med (Lausanne). 2022 Mar 10;9:838975. doi: 10.3389/fmed.2022.838975. eCollection 2022.

Results Reference

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Aquamin® as an Adjuvant Intervention for Ulcerative Colitis

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