Effect of a probiotic blend on bloating and colonic transit time in participants with self-reported bloating and constipation
| ISRCTN | ISRCTN41607808 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41607808 |
| Secondary identifying numbers | AFCRO-056 |
- Submission date
- 25/09/2015
- Registration date
- 02/10/2015
- Last edited
- 29/05/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Constipation is when a person is not passing stools regularly, or cannot completely empty their bowels. Women and the elderly are especially at increased risk for constipation. Constipation results in lower quality of life and significant healthcare costs. Bloating, a feeling of increased pressure within the abdomen, is a bothersome symptom that affects a third of the general population and almost all irritable bowel syndrome (IBS) patients. This study assesses the effect of a probiotic blend in people with bloating and constipation.
Who can participate?
People aged 18 - 70 with bloating and constipation
What does the study involve?
Participants are randomly allocated to take either a probiotic blend or placebo (dummy) capsule for 14 consecutive days. During the study, participants should avoid taking other probiotics or probiotic-containing products, prebiotics and nutritional supplements (vitamins or minerals such as calcium, magnesium or iron). They should also avoid making any significant changes to their diet and physical exercise habits during the study. Participants attend the clinic for five visits over a period of 4 weeks. Participants’ Colon Transit Time is measured at the start and end of the study. This is a measure of the time it takes for a meal to travel through your digestive system. Measuring Colon Transit Time requires that participants swallow something that can be tracked or traced as it travels through your digestive system. For this study, participants have to swallow a capsule containing small indigestible pellets, for six consecutive days. After the six days participants have an x-ray to show how the pellets have moved through their intestines. In addition, a stool sample is collected at home in advance of the day 0 and day 14 visits.
What are the possible benefits and risks of participating?
The probiotic may help to improve symptoms of bloating and constipation but there is no guarantee that being in this study will help. Information from this study might help researchers to improve the treatment of patients with constipation. The five strains in the probiotic have been tested previously and have been shown to be effective with no serious side effects. There are no allergens present in the probiotic blend or the capsules, so there should be no risk of an allergic reaction to these. There is a risk of an allergic reaction to the small indigestible pellets. For this reason, participants with allergies to barium sulfate or additives in polyurethane are excluded from the study as these conditions increase the risk of allergic reactions.
Where is the study run from?
Atlantia Food Trials (Ireland)
When is the study starting and how long is it expected to run for?
August 2015 to February 2016
Who is funding the study?
Danisco Sweeteners Oy (Finland)
Who is the main contact?
Mary Osborne
mosborne@atlantiafoodtrials.com
Contact information
Public
Atlantia Food Clinical Trials
Bridge House, Unit 2
Skehard Road
Blackrock
Cork
T12 H2TK
Ireland
| Phone | +353 (0)21 423 1000 |
|---|---|
| mosborne@atlantiafoodtrials.com |
Scientific
Atlantia Food Clinical Trials
Bridge House, Unit 2
Skehard Road
Blackrock
Cork
T12 H2TK
Ireland
Study information
| Study design | Randomized double-blinded placebo-controlled multicenter study with two arms and parallel groups |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Effect of a probiotic blend on bloating and colonic transit time in participants with self-reported bloating and constipation: a double-blind, randomized, placebo-controlled trial |
| Study objectives | To determine the effect of a 14-day supplementation of a probiotic blend on abdominal bloating in a generally healthy adult population suffering from bloating and constipation. |
| Ethics approval(s) | University College Cork, Clinical Research Ethics Committee, 18/08/2015, EC Ref ECM 4 (k) 11/08/15 |
| Health condition(s) or problem(s) studied | Abdominal bloating |
| Intervention | The investigational product (IP) is a mixture of five live freeze-dried Lactobacillus & Bifidobacterium strains. Microcrystalline cellulose (MCC) is added to the active blend as an inert carrier, and it functions as placebo as well. Neither IP contains any other active ingredients than the these bacterial strains. All of the probiotic strains included in the IP are manufactured by Danisco USA Inc. in accordance with U.S. Food & Drug Administration’s (FDA) regulations. All species included in the IP are considered safe for human consumption. Participants are randomized to take either the probiotic blend or placebo administered in capsules (1 capsule daily) for 14 days. There is no follow-up of the treatment arms. |
| Intervention type | Supplement |
| Primary outcome measure | The primary objective of the present clinical trial is to independently assess the effect of orally administered 2-week supplementation of a probiotic blend (or placebo) on bloating in general adult population with self-reported bloating and constipation. The probiotic blend (or placebo) will be administered in capsules (1 capsule daily) for 14 days (for strain-wise dosages in a capsule, see Table 1). The bloating severity and the number of days with bloating will be determined for 14 days with a daily eDiary using visual analogue scale (VAS). The primary endpoint will be a composite score of percentage of days with bloating times the average severity of the VAS, frequency*severity. |
| Secondary outcome measures | The secondary objectives of this clinical trial are to assess the effect of 2-week supplementation of a probiotic blend (or placebo) on the following parameters in adults with self-reported bloating and constipation: 1. Colonic transit time (CTT), determined by the amount of ingested ROMs visualized with X-ray 2. Participant assessment of digestive symptoms in addition to bloating (abdominal pain, flatulence/gas and borborgymi/burbling/rumbling), assessed daily for 14 days (Day 0 to Day 14) with an eDiary together with the primary outcome 3. Defecation frequency and stool consistency, assessed daily for 14 days (Day 0 to Day 14) with an eDiary together with the primary outcome 4. Constipated-related PAC-SYM and PAC-Qol questionnaries, assessed at baseline (Day 0) and at the end of the intervention (Day 14) 5. Faecal microbial analysis, assessed at baseline (within Day -6 until Day 0), and at the end of intervention (within Day 8 until Day 14) 6. Overall product satisfaction, evaluated at the end of the intervention (Day 14) Safety of the investigational product will be evaluated throughout the study on the basis of serious and non-serious adverse events, as outlined in Adverse Events. |
| Overall study start date | 01/08/2015 |
| Completion date | 26/02/2016 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 152 total, 76 per group |
| Total final enrolment | 156 |
| Key inclusion criteria | 1. Age 18 - 70 2. Obtained his/her informed consent after verbal and written information 3. Sufficient general health and orientation for participating in the study 4. Have a high probability for compliance with and completion of the study 5. Functional constipation or constipation predominant IBS according to Rome III criteria 6. Bowel movement frequency 1-3/week 7. Stool consistency 1-2 according to Bristol Stool Scale Form for most spontaneously passed stools 8. Self-reported bloating at least twice a week 9. No continuous use of probiotics or probiotic containing product or drug within 1 month prior to screening |
| Key exclusion criteria | 1. Participation in a clinical trial with an investigational product or drug within 2 months prior to screening 2. Likeliness to be non-compliant with the protocol, or to be unsuitable to the study by the investigator for any reason 3. Planned major changes in life style (diet, exercise level, travelling) 4. Eating disorder 5. Pregnant or breastfeeding women; women planning to become pregnant during the study 6. Subject under administrative or legal supervision 7. Diagnosed or suspected organic gastrointestinal disease 8. Severely impaired general health including cancer and cancer therapy 9. Prior major abdominal surgery 10. Lactose intolerance if the subject does not follow a lactose-restricted diet 11. Previous anaphylaxis type reaction to any substance in composition of the study product 12. Consumption of or unwillingness to refrain from the use of commercial probiotics or prebiotics during the trial 13. Laxative use within 48 hours of screening and regular use of laxatives (rescue medication allowed for intolerable symptoms during study) 14. Regular use of any drug or dietary supplement known to cause constipation as a common side effect (e.g. iron, opioids, sucralfate misoprostol, 5-HT#-antagonists, antacids with magnesium, calcium or aluminum, anti-diarrheal medication, anti-cholinergic agents, calcium supplements, tricyclic anti-depressants or NSAIDs) within 1 month prior to the study randomization 15. History of drug or alcohol abuse 16. Subject has been on antibiotics within 1 month of screening visit |
| Date of first enrolment | 30/09/2015 |
| Date of final enrolment | 12/02/2016 |
Locations
Countries of recruitment
- Ireland
Study participating centre
Bridge Water House
Skehard Road
Cork
T12 H2TK
Ireland
Sponsor information
Industry
Sokeritehtaantie 20
Kantvik
FI-02460
Finland
"ROR" |
https://ror.org/02nqcmv36 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/03/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | For data protection reasons, the trialists do not make public any information, coded or non-coded regarding the study participants. This coded information is being held in the company database which is in compliance with GDPR regulations. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 20/11/2017 | 20/11/2017 | No | No | |
| Results article | results | 10/07/2019 | 29/05/2019 | Yes | No |
Additional files
- ISRCTN41607808_BasicResults_20Nov17.pdf
- Uploaded 20/11/2017
Editorial Notes
29/05/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
20/11/2017: The basic results of this trial have been uploaded as an additional file.
16/11/2017: The intention to publish date has been added.
13/11/2017: IPD sharing statement added.
15/01/2016: The following changes were made to the trial record:
1. The recruitment end date was changed from 07/12/2015 to 12/02/2016.
2. The overall trial end date was changed from 31/12/2015 to 26/02/2016.
