Diarrhea
Conditions
Keywords
diarrhea, probiotics, diosmectite
Brief summary
Treatment diarrhea with Lactobacillus GG or smectite has proven efficacy. A randomized, double blind, placebo-control trial was performed to assess the effectiveness of both LGG and smectite in management of children with acute gastroenteritis (AGE).
Detailed description
ESPGHAN agreed to use probiotics, with proven efficacy, and smectite in treatment of AGE as an adjunct to standard rehydration therapy. Among probiotics Lactobacillus GG were found to be beneficial in meta-analyses. Treatment with LGG was associated with a significant reduction in diarrhea duration. A recent review systematically evaluated the efficacy of smectite in treating acute infections diarrhea in infants and children.
Interventions
DIETARY_SUPPLEMENTSmectite
Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.
DIETARY_SUPPLEMENTPlacebo
Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.
DIETARY_SUPPLEMENTLactobacillus GG
All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite
Sponsors
Medical University of Warsaw
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Months to 5 Years
Healthy volunteers
No
Inclusion criteria
* children \< 5 years old * diarrhea (defined as the passage of 3 or more loose or watery stools per day) for \> 1 day but \< 5 days * inform consent sing
Exclusion criteria
* diarrhea \< 1 or \> 5 days, * a recent history of diarrhea indicated either by parents/guardian or hospital case notes, * underlying chronic gastrointestinal disease, * undernutrition (weight/height ratio below the 5th percentile), * systematic infection, * immune defects or immunosuppressive treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Diarrhea | counted in days during 7days | The primary outcome measure is duration of diarrhea (counted in days; from the first loose stool to the last one; end of diarrhea defined as last loose stool or at least 12hours without stool). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Consistency of Stools | day 4-th | consistency of stools using Bristool Stool Scale Form on day 4-th. (The Bristol stool scale form is a medical aid designed to classify the form of human faeces into seven categories. Type 1 Separate hard lumps, like nuts (hard to pass) Type 2 Sausage-shaped but lumpy Type 3 Like a sausage but with cracks on the surface Type 4 Like a sausage or snake, smooth and soft Type 5 Soft blobs with clear-cut edges Type 6 Fluffy pieces with ragged edges, a mushy stool Type 7 Watery, no solid pieces. Entirely liquid Types 1-2 indicate constipation, with 3 and 4 being the ideal stools (especially the latter), as they are easy to defecate while not containing any excess liquid, and 5, 6 and 7 tending towards diarrhoea. |
| Need for Antibiotic Therapy, | yes/no, for 7days | need for antibiotic therapy because of diarrhea |
| Vomiting | yes/no, for 7days | If the child vomiting after randomization (yes/no) |
| Diarrhea Recurrence | 7 days | If the was a diarrhea recurrence during 7days |
| Frequency of Loose Stools, | number of loose stools during 7 days | number of loose stools during 7 days |
| Need for Hospitalization | 7 days | If the child need to hospitalized |
| Need for Intravenous Therapy | yes/no, for 7days | need for intravenous rehydration therapy (yes/no) |
| Duration of Intravenous Therapy | 7days | need for intravenous rehydration therapy (how long if needed) |
| Tolerance of Products | 7days | tolerance of products (whether the child took medicaments), |
Countries
Poland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lactobacillus GG and Smectite Children received:
* LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and
* smectite, dose 3 g, once daily orally until diarrhea stopped
Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.
Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite | 44 |
| Lactobacillus GG and Placebo Children received:
* LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and
* placebo (glucose), dose 3 g, once daily orally until diarrhea stopped
Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.
Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite | 44 |
| Total | 88 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 7 |
Baseline characteristics
| Characteristic | Lactobacillus GG and Smectite | Lactobacillus GG and Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 44 Participants | 44 Participants | 88 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 17.5 months | 18 months | 18 months |
| Region of Enrollment Poland | 44 participants | 44 participants | 88 participants |
| Sex: Female, Male Female | 23 Participants | 15 Participants | 38 Participants |
| Sex: Female, Male Male | 21 Participants | 29 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 44 | 0 / 37 |
| serious Total, serious adverse events | 0 / 44 | 0 / 37 |
Outcome results
Primary
Duration of Diarrhea
The primary outcome measure is duration of diarrhea (counted in days; from the first loose stool to the last one; end of diarrhea defined as last loose stool or at least 12hours without stool).
Time frame: counted in days during 7days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lactobacillus GG and Smectite | Duration of Diarrhea | 2 days |
| Lactobacillus GG and Placebo | Duration of Diarrhea | 2 days |
p-value: 0.43Wilcoxon (Mann-Whitney)
Secondary
Consistency of Stools
consistency of stools using Bristool Stool Scale Form on day 4-th. (The Bristol stool scale form is a medical aid designed to classify the form of human faeces into seven categories. Type 1 Separate hard lumps, like nuts (hard to pass) Type 2 Sausage-shaped but lumpy Type 3 Like a sausage but with cracks on the surface Type 4 Like a sausage or snake, smooth and soft Type 5 Soft blobs with clear-cut edges Type 6 Fluffy pieces with ragged edges, a mushy stool Type 7 Watery, no solid pieces. Entirely liquid Types 1-2 indicate constipation, with 3 and 4 being the ideal stools (especially the latter), as they are easy to defecate while not containing any excess liquid, and 5, 6 and 7 tending towards diarrhoea.
Time frame: day 4-th
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lactobacillus GG and Smectite | Consistency of Stools | 5 Units on a scale |
| Lactobacillus GG and Placebo | Consistency of Stools | 4 Units on a scale |
Secondary
Diarrhea Recurrence
If the was a diarrhea recurrence during 7days
Time frame: 7 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lactobacillus GG and Smectite | Diarrhea Recurrence | 3 participants |
| Lactobacillus GG and Placebo | Diarrhea Recurrence | 3 participants |
Secondary
Duration of Intravenous Therapy
need for intravenous rehydration therapy (how long if needed)
Time frame: 7days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lactobacillus GG and Smectite | Duration of Intravenous Therapy | 1 days |
| Lactobacillus GG and Placebo | Duration of Intravenous Therapy | 1 days |
Secondary
Frequency of Loose Stools,
number of loose stools during 7 days
Time frame: number of loose stools during 7 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lactobacillus GG and Smectite | Frequency of Loose Stools, | 10.5 number of loose stools during 7days |
| Lactobacillus GG and Placebo | Frequency of Loose Stools, | 10 number of loose stools during 7days |
Secondary
Need for Antibiotic Therapy,
need for antibiotic therapy because of diarrhea
Time frame: yes/no, for 7days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lactobacillus GG and Smectite | Need for Antibiotic Therapy, | 0 participants |
| Lactobacillus GG and Placebo | Need for Antibiotic Therapy, | 0 participants |
Secondary
Need for Hospitalization
If the child need to hospitalized
Time frame: 7 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lactobacillus GG and Smectite | Need for Hospitalization | 34 participants |
| Lactobacillus GG and Placebo | Need for Hospitalization | 31 participants |
Secondary
Need for Intravenous Therapy
need for intravenous rehydration therapy (yes/no)
Time frame: yes/no, for 7days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lactobacillus GG and Smectite | Need for Intravenous Therapy | 23 participants |
| Lactobacillus GG and Placebo | Need for Intravenous Therapy | 25 participants |
Secondary
Tolerance of Products
tolerance of products (whether the child took medicaments),
Time frame: 7days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lactobacillus GG and Smectite | Tolerance of Products | 34 participants |
| Lactobacillus GG and Placebo | Tolerance of Products | 32 participants |
Secondary
Vomiting
If the child vomiting after randomization (yes/no)
Time frame: yes/no, for 7days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lactobacillus GG and Smectite | Vomiting | 9 participants |
| Lactobacillus GG and Placebo | Vomiting | 11 participants |
Secondary
Vomiting
How many times the child was vomiting (during the study)
Time frame: how many times for 7days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lactobacillus GG and Smectite | Vomiting | 0 vomiting episodes |
| Lactobacillus GG and Placebo | Vomiting | 0 vomiting episodes |