The beneficial effect of ingestion of a food supplement based on a pool of digestive enzymes in people with functional dyspepsia
| ISRCTN | ISRCTN67691215 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67691215 |
| Secondary identifying numbers | DISPEPSIA22_01 |
- Submission date
- 14/06/2023
- Registration date
- 28/06/2023
- Last edited
- 29/11/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English Summary
Background and study aims
Functional dyspepsia represents a problem for society, both in terms of health costs and the worsening of the quality of life of patients. Symptoms reported by patients with dyspepsia include bloating, early satiety, postprandial fullness, nausea, anorexia, heartburn, regurgitation, and frequent belching.
A deficiency or possible dysfunction of digestive enzymes may be an important factor in dyspepsia. Digestive enzymes aid digestion by breaking down carbohydrates, proteins, and lipids, promoting their absorption. It therefore may be useful to create products composed of these enzymes that are stable in the intestinal environment and are able to improve the pre-existing enzymatic activity. In fact, there are some clinical studies which demonstrate the positive effect of a variety of digestive enzymes, also used in combination or in addition to probiotics.
The aim of this study is to evaluate the effectiveness of supplementing the diet with a pool of digestive enzymes, at improving functional dyspepsia symptoms and quality of life.
Who can participate?
Patients aged 18-59 years who have functional dyspepsia
What does the study involve?
Participants are randomly allocated to consume a food supplement containing digestive enzymes or a placebo (dummy) for 60 days.
What are the possible benefits and risks of participating?
No risks are foreseen. Participants taking the food supplement may experience an improvement in dyspepsia symptoms and quality of life. However, there may be no benefit.
Where is the study run from?
Comegen, Naples (Italy)
When is the study starting and how long is it expected to run for?
October 2022 to September 2023
Who is funding the study?
Istituto Nazionale Biostrutture e Biosistemi (Italy)
Who is the main contact?
1. Prof. Maria Daglia (scientific) maria.daglia@unina.it
2. Dr. Alessandra Baldi (public) alessandra.baldi.alimenti@gmail.com
Contact information
Public
Viale delle Medaglie d’Oro, 305
Rome
00136
Italy
 ORCID ID |
0000-0002-2877-9445 |
|---|---|
| Phone | +39 (0)3483854114 |
| alessandra.baldi.alimenti@gmail.com |
Scientific
Via Domenico Montesano
Naples
80013
Italy
| ORCID ID |
0000-0002-4870-7713 |
|---|---|
| Phone | +39 (0)81 77623 |
| maria.daglia65@gmail.com |
Study information
| Study design | Interventional monocentric randomized parallel double-blind placebo-controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | GP practice |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Evaluation of the efficacy of digestive enzyme supplementation in patients with functional dyspepsia for the improvement of quality of life: randomized, double-blind, placebo-controlled, monocentric, clinical study |
| Study acronym | DISPEPSIA22 |
| Study hypothesis | The aim of this study was to evaluate the effectiveness of supplementing the diet with a pool of digestive enzymes, in improving functional dyspepsia symptoms, and, consequently, the individual's quality of life. |
| Ethics approval(s) |
Approved 07/11/2022, Comitato Etico Campania Centro (Strada Comunale del Principe 13/a, Naples, 80145, Italy; +39 (0)812544515; COMITATOETICO@aslnapoli1centro.it), ref: 591 |
| Condition | Functional dyspepsia |
| Intervention | The subjects recruited in the present clinical study will consume a food supplement based on a pool of digestive enzymes derived from fungal microorganisms (amylase, protease, and lactase from Aspergillus oryzae, cellulase from Trichoderma reesei, lipase form Rhizopus oeyzae) or a placebo for 60 days based on the randomization group. The randomization sequence will be generated by a statistician using STATA 16 software (Stata Statistical Software: Release 16. College Station, TX: StataCorp LLC) and the randomization list will be kept hidden. The participants will be assigned to each of the two treatment groups (food supplement or placebo) casually and by simple randomization (1:1 allocation ratio). The randomization code will consist of a three-digit number as indicated in the respective Case Report Form (CRF). In the clinical study, 120 participants will be enrolled and divided into two groups (60 for each group): Group 1: food supplement containing the pool of digestive enzymes. Group 2: placebo. The supplementation consists of two capsules/day for a total dosage of 400 mg/die of the digestive enzyme pool. Participants will undergo four visits (baseline = t0; after 30 days of treatment = t1; after 60 days of treatment = t2) in an outpatient setting. After each clinical visit, all data are filled in the CRF by physicians. During the screening visit, subjects will undergo the following investigation to understand if they meet the study participation requirements: Functional dyspepsia diagnosis confirmation, using Rome IV criteria, which predict, in an individual who does not present organic causes, the occurrence of at least one of the following symptoms, in the 6 months preceding the diagnosis: 1. Postprandial filling (at least 3 days in a week) 2. Early satiety (at least 3 days in a week) 3. Epigastric pain (at least 1 day in a week) 4. Heartburn (at least 1 day in a week) Adherence to the Rome IV criteria for functional dyspepsia must have been met for at least 3 months. Subsequently, all enrolled subjects will undergo the following: At t0, t1 and t2 (at baseline, 30 and 60 days from the start of treatment) filling the Nepean Dyspepsia Index-Short Form (NDI-SF), Pittsburgh Sleep Quality Index (PSQI) questionnaires, and a Visual Analogue Scale (VAS) for general perceived pain evaluation, administered by the investigating physician. |
| Intervention type | Supplement |
| Primary outcome measure | Functional dyspepsia symptoms measured using the Nepean Dyspepsia Index-SF (NDI-SF) at baseline (t0), 30 days (t1), 60 days of treatment (t2) |
| Secondary outcome measures | 1. Perceived general pain measured using the Visual Analog Scale (VAS) at baseline (t0), 30 days (t1), 60 days of treatment (t2) 2. Sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI) at baseline (t0), 30 days (t1), 60 days of treatment (t2) |
| Overall study start date | 03/10/2022 |
| Overall study end date | 01/09/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 59 Years |
| Sex | Both |
| Target number of participants | 120 |
| Total final enrolment | 120 |
| Participant inclusion criteria | 1. Aged 18-59 years of both sexes 2. Diagnosis of functional dyspepsia according to the Rome IV criteria 3. Have not taken antibiotics or other drugs whose primary site of action is the gastrointestinal tract in the month prior to screening, except those used in the treatment of functional dyspepsia itself (drug intake has been recorded) 4. Have agreed not to significantly modify their normal eating habits during the study period 5. Not using other food supplements throughout the study period 6. Able to understand and sign the informed consent |
| Participant exclusion criteria | 1. Aged <18 and >59 years 2. Have a medical history or condition that could affect the subject's safety or negatively impact the validity of the study results 3. Pregnant or breastfeeding women 4. Cognitive impairments which could hinder the response to questionnaires 5. History of allergy to ingredients contained in the study treatments (dietary supplement and placebo) 6. Using drugs that could interfere with gastrointestinal motility, except those used in the treatment of functional dyspepsia itself (drug intake has been recorded) 7. Other pathologies of the gastrointestinal system (gastroesophageal reflux, irritable bowel syndrome [IBS], small intestinal bacterial overgrowth [SIBO]) 8. Malabsorption 9. History of addiction or abuse of medications or drugs 10. Continued to abuse alcohol over time (alcoholics), smokers or ex-smokers who have quit less than a year ago 11. Celiac disease 12. Eating disorders 13. Heart disease 14. Chronic hepatic, biliary and pancreatic pathologies, neoplastic pathologies, genetic-metabolic diseases or diabetes |
| Recruitment start date | 16/06/2023 |
| Recruitment end date | 23/06/2023 |
Locations
Countries of recruitment
- Italy
Study participating centre
Naples
80126
Italy
Sponsor information
Research organisation
Viale delle Medaglie d’Oro, 305
Rome
00136
Italy
| Phone | +39 (0)6 35340153 |
|---|---|
| inbb@pec.inbb.it | |
| Website | http://www.inbb.it/ |
"ROR" |
https://ror.org/043bhwh19 |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 01/09/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a high-impact peer-review journal. |
| IPD sharing plan | The datasets generated and/or analyzed during the current study will be published as a supplement to the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 14/11/2023 | 29/11/2023 | Yes | No |
Editorial Notes
29/11/2023: Publication reference and total final enrolment added.
15/06/2023: Study's existence confirmed by the Comitato Etico Campania Centro.
