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  • HP:0002019: Constipation
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    HP:0002019: Constipation

    Developed by Shray Alag, The Harker School
    Sections: Correlations, Clinical Trials, and HPO

    Correlations computed by analyzing all clinical trials.

    Navigate: Clinical Trials and HPO


    Correlated Drug Terms (3)


    Name (Synonyms) Correlation
    drug2756 PDS-08 Wiki 1.00
    drug1833 Hyperbaric oxygen therapy Wiki 1.00
    drug2916 Placebo Wiki 0.04

    Correlated MeSH Terms (2)


    Name (Synonyms) Correlation
    D012817 Signs and Symptoms, Digestive NIH 1.00
    D003248 Constipation NIH 1.00

    Correlated HPO Terms (0)


    Name (Synonyms) Correlation

    Clinical Trials

    Navigate: Correlations   HPO

    There is one clinical trial.


    1 A 12-week Randomized, Double-Blind Controlled Trial to Evaluate the Tolerability and Gastrointestinal Response of a Novel, Multi-Strain Synbiotic (PDS-08™) in Children Ages 3-17

    Recent data support the use of specific probiotic strains in a pediatric population. However, given the wide number of commercial products available, and contradictory data in the literature, healthcare providers and consumers are uncertain about whether or not to use probiotics in children and which one(s) to choose. While much progress has been made in understanding the gastrointestinal microbiota and its role in the balanced development of the infant immune system, the tolerability and efficacy of introducing beneficial microbes into the pediatric gastrointestinal tract remain underexplored. The purpose of this study is to investigate the effect of a 9 strain synbiotic consortium comprised of strains with previous pediatric clinical data for use in modulating airway sensitivity, gastrointestinal discomfort, dermatological inflammation, and reduction in the duration and severity of upper respiratory tract infections in a pediatric population.

    NCT04534036
    Conditions
    1. Constipation
    2. Signs and Symptoms
    3. Digestive Signs and Symptoms
    4. Infrequent or Difficult Evacuation
    Interventions
    1. Dietary Supplement: PDS-08
    2. Other: Placebo
    MeSH:Constipation Signs and Symptoms, Digestive
    HPO:Colonic inertia Constipation

    Primary Outcomes

    Description: Assessed as the change from baseline and compared to placebo for the continuous variable estimated using a linear mixed model.

    Measure: Percentage of participants who are spontaneous bowel movement responders, defined as having an average of ≥ 4 complete spontaneous bowel movements (CSBMs) per week and an average increase of ≥ 1 CSBM from baseline, by age group: 3-6, 7-12, 13-17 years.

    Time: Baseline-Day 84

    Secondary Outcomes

    Description: Assessed by daily stool characteristics reported using the seven-point ordinal BSFS score. The BSFS classifies human stool into seven types and scores them accordingly. Type 1: Separate hard lumps (hard to pass) Type 2: Sausage-shaped and lumpy Type 3: Like a sausage but with cracks on its surface Type 4: Like a sausage, smooth and soft Type 5: Soft blobs with clear cut edges (passed easily) Type 6: Fluffy pieces with ragged edges, a mushy stool Type 7: Watery, no solid pieces, entirely liquid. Types 1 and 2 indicate constipation, with 3 through 5 represent the ideal stool form, and 6 and 7 tend towards diarrhea. For a given assessment week, the weekly stool consistency is defined as the sum of non-missing stool consistency score for spontaneous bowel movements during that week divided by the number of non-missing stool consistency scores for spontaneous bowel movements during that week. The parameter will be analyzed using a linear mixed model.

    Measure: Average increase from baseline of Bristol Stool Form Scale (BSFS) score by ≥ 1 point (stool characterized as an increase to either type 2 or 3 or 4) in the intervention group, compared to the placebo group.

    Time: Baseline-Day 84

    Measure: Decrease of ≥ 10% in time spent emptying bowel from beginning to end of bowel movement, compared to baseline.

    Time: Baseline-Day 84

    Description: Assessed by online daily symptom-tracking of stool-quality, regularity, ease of expulsion, bloating, and flatulence.

    Measure: Changes in subjective assessment of gut tolerability as reported by parents or direct relative guardians, indicated by sustained (longer than 7 days of) abdominal pain, severe bloating, heartburn, acid reflux, or indigestion.

    Time: Baseline-Day 84

    Description: Microbiota composition will be identified through fecal samples for total genomic DNA extraction in participants supplemented with PDS-08 or placebo. Metagenomic sequencing will yield a total observable species count and maintenance will be defined as within 20% of the total observed species count when compared to baseline.

    Measure: Maintenance or increase of diversity within the PDS-08 treatment group.

    Time: Baseline-Day 84

    Measure: Significant increase in QoL measured by the KINDL questionnaire with respect to mean change from baseline score (p<0.05).

    Time: Baseline-Day 84

    Measure: Exploratory: number of respiratory tract infections in the PDS-08 group compared to placebo.

    Time: Baseline-Day 84

    Measure: Exploratory: number and percent of participants with reduction in number of acne lesions from baseline as measured by global count of blemishes.

    Time: Baseline-Day 84

    Measure: Exploratory outcomes: changes in fecal calprotectin, histamine, bacterial enzymes (β-glucosidase and β-glucuronidase), β-defensin (hBD2) and short chain fatty acids in treatment group compared to the placebo group.

    Time: Baseline-Day 84

    HPO Nodes


    HP:0002019: Constipation
    Genes 478
    ZIC2 TRIO POGZ CAMTA1 TRNL1 NRXN1 NODAL COL5A1 DNAJC13 POLG LIMK1 PRNP EXT2 COL7A1 VANGL1 SIX3 SDHC TSHR GP1BB SNCA LAMA3 HFE MAPT MLXIPL SALL1 PAX8 AVPR2 SEC24C TTR CAMK2B HNRNPK ATXN2 THRA UBE3A SCNN1A NKX2-5 PRKN DEAF1 DISP1 GAS1 SOX2 ADH1C CDC73 CACNA1S LRRK2 FOXH1 MECP2 BIRC3 ELN SCN11A MAGEL2 DNAJC6 OCRL ASCL1 JMJD1C UFD1 CREBBP HNRNPH2 TSHR COX2 DLL1 TXNRD2 SIX3 NKX2-5 GTF2I MBD5 MLH3 NSD1 FAN1 FOXG1 VPS11 RORA SLC26A4 MSH2 TG FOXH1 SETD5 DDOST KMT2A EDN3 CDON EDNRB TCF4 LHX3 OTX2 TLK2 GAS1 SMO OTUD6B KCNJ1 TRNH MRAP SLC5A5 KRT14 UFC1 RET COL5A2 TTR SPOP IGH NODAL BRAF RET LHX4 PSMB8 ACTG2 SHH DISP1 MNX1 MECP2 DSE POU1F1 NKX2-1 CSNK2A1 KIT GLI2 COL1A1 HIVEP2 TBCD RERE SCN9A TANC2 WDR26 DISP1 LMNB1 SIX3 ARNT2 POLG TWNK SLC6A8 FGF8 MEFV TDGF1 TGFBR2 CHST14 AQP2 LRIG2 TRNS2 GLI2 FGF8 TRNS1 STAT6 POU1F1 NR4A2 FGFR1 STAR CREBBP ZEB2 GABRA3 WFS1 ATN1 ND4 CDKL5 PAX8 ND5 PCCB CDON WAC STAG2 OCRL STXBP1 WASF1 FLI1 SIX3 COX1 RAI1 NGLY1 PCCA PIK3CA CAMTA1 DDOST KIT HPSE2 CTNS ZIC2 AQP2 ATRX FOXP1 PROP1 KRAS FGF8 PROKR2 SHH CNTNAP2 HMBS DHPS TH STAG2 PCGF2 NODAL SLC26A4 PTCH1 ZIC2 LMX1B NAB2 TRHR GAS1 ECE1 SLC5A5 TCF4 TRNF HESX1 FTL DUOXA2 DYRK1A UBE3B CDON DPF2 TYMP KCNJ18 UCHL1 TSHR PACS1 NNT CDKN1A MSL3 PTCH1 GLI2 SLC6A3 TCF4 TSHB SNCAIP COQ2 PACS1 ZEB2 CHST14 PARK7 SLC25A4 SLC12A3 NRTN ZMIZ1 SDHA SMC1A SCN10A CASR KRT5 CHCHD2 MLH1 NALCN MC2R KIT SPART GIGYF2 SOX3 PCCA HPSE2 FOXA2 SIK3 TRNK CDKN1B MEN1 PINK1 MRPS34 DDHD2 HMBS TCF20 PHOX2B CAVIN1 GDNF ADNP NRXN1 RET GLUD2 ABL1 MED25 SETD2 RREB1 PROP1 BMPR1A CD96 TRNL1 ARVCF ATRX GALNT2 PMS1 EDNRB ALDOB CLIP2 PDGFRA TBX1 IGHMBP2 POGZ PIGS SYNJ1 BRCA1 ODC1 BAZ1B ZSWIM6 LAMC2 PPOX LHX4 P4HTM GBA RAI1 UGP2 TRNQ RRM2B AFF4 TRH RFC2 SIX3 TDGF1 SEMA3C CDKN2C SLC6A3 PODXL USP7 ATRX HESX1 MLYCD GATAD2B CDON GDNF B2M OTUD6B MAGEL2 ALAD FDFT1 PPM1D EDN3 MED12L RAI1 GJC2 ZIC2 HESX1 LRRK2 GLI2 ARID2 EPCAM FOXE1 SPATA5 COX3 SLC6A8 FOXH1 TRIO EXT2 BCL10 VPS13C SNCA ND1 VPS35 EIF4G1 FGF8 ATRX GABRD POLG2 EP300 APC SOX3 SLC12A3 KCNAB2 TGIF1 WAC POLG2 GRIN1 DHCR7 PTCH1 DES TDGF1 CLCNKB VPS51 MMP1 SHH SCNN1B AVPR2 GLI2 CHRM3 SKI RPS20 GBA SDHB CREBBP GAS1 FOXG1 PROP1 COMT UNC80 TBX1 TGIF1 CDC73 WAC SCNN1G GTF2IRD1 MEFV PAX8 SCN11A PIGV LAMB3 IYD NFIX DEAF1 PTCH1 FGF12 ADAT3 FOXH1 RAI1 TAF1 FLII MALT1 NALCN SOX10 TGIF1 MDH2 SEMA4A SLC12A1 MED13 FLNA KCNH1 KDM1A APC2 FGFR1 PPOX ALPL EP300 TDGF1 TRNW DLL1 SHH RET TPO TGIF1 MED12 TBP PEX16 EP300 SOX10 TBCD MSH6 TNFRSF1A FOXP1 SCN9A ND6 FGFR1 ATXN8OS UBE2A SMPD1 POLG CREBBP CHD8 ELN PCCB CPOX WDR26 SDHC PAX8 DUOX2 ELP1 CISD2 NODAL COL7A1 DDC EDN3 TBL2 DLL1 COQ2 MED12 CDKN2B VPS11 HIRA LRIG2 SRCAP MITF IQSEC2 DMPK OTX2 PMS2 DLL1 PRDM16 SDHB ZEB2 DACT1 SEMA3D HTRA2 TBL1X UNC80 DISP1 SH2B1 TRNE
    Protein Mutations 2
    G1314A G1321A
    SNP 0

    HPO

    Alphabetical listing of all HPO terms. Navigate: Correlations   Clinical Trials


    HPO Nodes


    HP:0002019: Constipation
    Genes 478
    ZIC2 TRIO POGZ CAMTA1 TRNL1 NRXN1 NODAL COL5A1 DNAJC13 POLG LIMK1 PRNP EXT2 COL7A1 VANGL1 SIX3 SDHC TSHR GP1BB SNCA LAMA3 HFE MAPT MLXIPL SALL1 PAX8 AVPR2 SEC24C TTR CAMK2B HNRNPK ATXN2 THRA UBE3A SCNN1A NKX2-5 PRKN DEAF1 DISP1 GAS1 SOX2 ADH1C CDC73 CACNA1S LRRK2 FOXH1 MECP2 BIRC3 ELN SCN11A MAGEL2 DNAJC6 OCRL ASCL1 JMJD1C UFD1 CREBBP HNRNPH2 TSHR COX2 DLL1 TXNRD2 SIX3 NKX2-5 GTF2I MBD5 MLH3 NSD1 FAN1 FOXG1 VPS11 RORA SLC26A4 MSH2 TG FOXH1 SETD5 DDOST KMT2A EDN3 CDON EDNRB TCF4 LHX3 OTX2 TLK2 GAS1 SMO OTUD6B KCNJ1 TRNH MRAP SLC5A5 KRT14 UFC1 RET COL5A2 TTR SPOP IGH NODAL BRAF RET LHX4 PSMB8 ACTG2 SHH DISP1 MNX1 MECP2 DSE POU1F1 NKX2-1 CSNK2A1 KIT GLI2 COL1A1 HIVEP2 TBCD RERE SCN9A TANC2 WDR26 DISP1 LMNB1 SIX3 ARNT2 POLG TWNK SLC6A8 FGF8 MEFV TDGF1 TGFBR2 CHST14 AQP2 LRIG2 TRNS2 GLI2 FGF8 TRNS1 STAT6 POU1F1 NR4A2 FGFR1 STAR CREBBP ZEB2 GABRA3 WFS1 ATN1 ND4 CDKL5 PAX8 ND5 PCCB CDON WAC STAG2 OCRL STXBP1 WASF1 FLI1 SIX3 COX1 RAI1 NGLY1 PCCA PIK3CA CAMTA1 DDOST KIT HPSE2 CTNS ZIC2 AQP2 ATRX FOXP1 PROP1 KRAS FGF8 PROKR2 SHH CNTNAP2 HMBS DHPS TH STAG2 PCGF2 NODAL SLC26A4 PTCH1 ZIC2 LMX1B NAB2 TRHR GAS1 ECE1 SLC5A5 TCF4 TRNF HESX1 FTL DUOXA2 DYRK1A UBE3B CDON DPF2 TYMP KCNJ18 UCHL1 TSHR PACS1 NNT CDKN1A MSL3 PTCH1 GLI2 SLC6A3 TCF4 TSHB SNCAIP COQ2 PACS1 ZEB2 CHST14 PARK7 SLC25A4 SLC12A3 NRTN ZMIZ1 SDHA SMC1A SCN10A CASR KRT5 CHCHD2 MLH1 NALCN MC2R KIT SPART GIGYF2 SOX3 PCCA HPSE2 FOXA2 SIK3 TRNK CDKN1B MEN1 PINK1 MRPS34 DDHD2 HMBS TCF20 PHOX2B CAVIN1 GDNF ADNP NRXN1 RET GLUD2 ABL1 MED25 SETD2 RREB1 PROP1 BMPR1A CD96 TRNL1 ARVCF ATRX GALNT2 PMS1 EDNRB ALDOB CLIP2 PDGFRA TBX1 IGHMBP2 POGZ PIGS SYNJ1 BRCA1 ODC1 BAZ1B ZSWIM6 LAMC2 PPOX LHX4 P4HTM GBA RAI1 UGP2 TRNQ RRM2B AFF4 TRH RFC2 SIX3 TDGF1 SEMA3C CDKN2C SLC6A3 PODXL USP7 ATRX HESX1 MLYCD GATAD2B CDON GDNF B2M OTUD6B MAGEL2 ALAD FDFT1 PPM1D EDN3 MED12L RAI1 GJC2 ZIC2 HESX1 LRRK2 GLI2 ARID2 EPCAM FOXE1 SPATA5 COX3 SLC6A8 FOXH1 TRIO EXT2 BCL10 VPS13C SNCA ND1 VPS35 EIF4G1 FGF8 ATRX GABRD POLG2 EP300 APC SOX3 SLC12A3 KCNAB2 TGIF1 WAC POLG2 GRIN1 DHCR7 PTCH1 DES TDGF1 CLCNKB VPS51 MMP1 SHH SCNN1B AVPR2 GLI2 CHRM3 SKI RPS20 GBA SDHB CREBBP GAS1 FOXG1 PROP1 COMT UNC80 TBX1 TGIF1 CDC73 WAC SCNN1G GTF2IRD1 MEFV PAX8 SCN11A PIGV LAMB3 IYD NFIX DEAF1 PTCH1 FGF12 ADAT3 FOXH1 RAI1 TAF1 FLII MALT1 NALCN SOX10 TGIF1 MDH2 SEMA4A SLC12A1 MED13 FLNA KCNH1 KDM1A APC2 FGFR1 PPOX ALPL EP300 TDGF1 TRNW DLL1 SHH RET TPO TGIF1 MED12 TBP PEX16 EP300 SOX10 TBCD MSH6 TNFRSF1A FOXP1 SCN9A ND6 FGFR1 ATXN8OS UBE2A SMPD1 POLG CREBBP CHD8 ELN PCCB CPOX WDR26 SDHC PAX8 DUOX2 ELP1 CISD2 NODAL COL7A1 DDC EDN3 TBL2 DLL1 COQ2 MED12 CDKN2B VPS11 HIRA LRIG2 SRCAP MITF IQSEC2 DMPK OTX2 PMS2 DLL1 PRDM16 SDHB ZEB2 DACT1 SEMA3D HTRA2 TBL1X UNC80 DISP1 SH2B1 TRNE
    Protein Mutations 2
    G1314A G1321A
    SNP 0

    Reports

    Data processed on September 26, 2020.

    An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

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