Carrageenan in ulcerative colitis
| ISRCTN | ISRCTN90354393 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90354393 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | HUS/770/2021 |
| Sponsor | Juhani Aho Medical Research Foundation |
| Funder | BoostOn Oy Ltd |
- Submission date
- 19/10/2021
- Registration date
- 25/10/2021
- Last edited
- 13/02/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Carrageenan is a common food additive extracted from red seaweed. It may cause increased immune activity and colitis (inflammation in the large bowel). However, carrageenan is approved for use by the European Food Safety Authority (EFSA) and US Food and Drug Administration (FDA) and is consumed regularly by Western populations. While some data from animal tests suggest that carrageenan is proinflammatory, there is only very limited data in humans. The aim of this study is to find out whether food-grade carrageenan causes gastrointestinal (digestive) symptoms, inflammation and hyperpermeability (leaky gut) in patients with ulcerative colitis when consumed at a high normal level according to the EU standard population.
Who can participate?
Patients aged 18-64 years with ulcerative colitis which is in clinical remission (no symptoms)
What does the study involve?
The study starts with a 7-day run-in period where participants consume a low carrageenan diet, as instructed by a dietician, then the participants are randomly allocated to consume either 2-2.5 g per day of carrageenan or a corresponding dose of oat fiber for 7 days, followed by at least 14 days break (may be slightly longer for some if the 14-day period is not possible for practical reasons), then the other treatment (either carrageenan or oat fiber) for 7 days.
What are the possible benefits and risks of participating?
The participants will get detailed information on their gut health, will help to progress science on gastrointestinal health and nutrition, and will also will get an appointment with a dietician for free after the study is finished. The potential risks to the participants include mild gastrointestinal symptoms and minor pain during the blood tests and mild bruising of the forearm after the blood tests.
Where is the study run from?
Selex Lab (Finland)
When is the study starting and how long is it expected to run for?
January 2021 to December 2022
Who is funding the study?
BoostOn Oy Ltd (Finland)
Who is the main contact?
Dr Reijo Laatikainen
reijo.laatikainen@booston.fi
Contact information
Scientific
Haapatie 25 B
Helsinki
00780
Finland
 ORCID ID |
0000-0003-2907-0291 |
|---|---|
| Phone | +358 (0)407171753 |
| reijo.laatikainen@booston.fi |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized controlled cross-over trial |
| Secondary study design | Randomised cross over trial |
| Study type | Participant information sheet |
| Scientific title | Carrageenan in ulcerative colitis: a randomised controlled trial |
| Study acronym | CARRAUC |
| Study objectives | Carrageenan may cause immune activation in ulcerative colitis. |
| Ethics approval(s) | Approved 07/04/2021, Helsinki and Uusimaa Hospital District Ethics Committee II (HUS Central Registry Office, Marjaniementie 74, Iiris Center, 00930, Helsinki, Finland; +358 (0)50 428 7386; anna.pallari@hus.fi), ref: HUS/770/2021 |
| Health condition(s) or problem(s) studied | Ulcerative colitis |
| Intervention | Carrageenan 2-2.5 g/day vs oat fiber, corresponding dose The study starts with a 7-day run-in period (low carrageenan diet, instructed by a dietician), then either a carrageenan period or an oat fiber (control) period for 7 days, followed by at least 14 days' washout (may be slightly longer for some if the 14-day period is not possible for practical reasons), then after the washout the other treatment (either carrageenan or control). This makes altogether 35 days including one run-in period, one washout period and two treatment periods. Randomisation: generated by an automated computer service (https://www.sealedenvelope.com/simple-randomiser/v1/lists ) in blocks of four. |
| Intervention type | Supplement |
| Primary outcome measure(s) | Colitis activity measured using the Simple Clinical Colitis Assessment Index (SCCAI) at baseline and the 7th day of both treatment periods |
| Key secondary outcome measure(s) | 1. Gastrointestinal symptoms measured by Visual Analog Scale (VAS) 0-100 at baseline and the 1st, 3rd and 7th day of both treatment periods at the end of the each day 2. Laboratory tests using blood, urine and stool samples at baseline and at the end (7th day) of both treatment periods: 2.1. Fecal calprotectin 2.2. hs-CRP 2.3. S-FABP-2 (intestinal permeability marker) 2.4. U-creatinine 2.5. U-Albumin 2.6. F-albumin 2.7. F-IgG 2.8. F-intestinal alkaline phosphatase (IAP) 3. Macronutrient and fiber intake measured using a food diary at the end of both treatment periods covering days 5, 6 and 7 (i.e. a 3-day food diary) |
| Completion date | 01/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 64 Years |
| Sex | All |
| Target sample size at registration | 16 |
| Total final enrolment | 8 |
| Key inclusion criteria | 1. Ulcerative colitis, clinical remission verified by normal fecal calprotectin 2. Aged 18-64 years 3. No biological medications or systemic cortisone usage for relapse |
| Key exclusion criteria | 1. Pregnancy/lactation 2. Currently participating in another clinical intervention study 3. Intestinal surgery 4. Cancer 5. Other severe illness which might affect the patient's ability to participate in the study |
| Date of first enrolment | 23/08/2021 |
| Date of final enrolment | 01/05/2022 |
Locations
Countries of recruitment
- Finland
Study participating centre
Helsinki
00100
Finland
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | Patient-level data available upon reasonable request from Dr Reijo Laatikainen (reijo.laatikainen@booston.fi) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 30/10/2023 | 13/02/2025 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version 2 | 30/03/2021 | 10/08/2022 | No | No |
Additional files
Editorial Notes
13/02/2025: Publication reference added.
12/08/2022: Total final enrolment and IPD sharing statement added.
10/08/2022: Protocol file uploaded.
25/10/2021: Trial's existence confirmed by the Helsinki and Uusimaa Hospital District Ethics Committee II.
